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WHOGuidelinesforSafeSurgery PDF
WHOGuidelinesforSafeSurgery PDF
The WHO Guidelines for Safe Surgery, First Edition, is intended to be issued as a Second Edition in 2009.
At present it is important for countries and organizations to note that the guidelines represent a consensus of
international experts and up to date technical information on safe surgery across the world.
The guidelines are being implemented for testing purposes in several hospitals across the six WHO regions
and changes may be made to some of the technical content of the chapters in light of results.
We welcome formal feedback on these guidelines. Feedback is invited using the AGREE methodology
http://www.agreecollaboration.org/pdf/agreeinstrumentfinal.pdf
WHO/IER/PSP/2008.08-1E
3
Table of contents
Section I.
Introduction
The problem: Complications of surgical care have become a major cause of death and
disability worldwide
The Safe Surgery Saves Lives Challenge: Identifying solutions
Transformation of risk during anaesthesia
The time out or surgical pause
Use of a checklist for central line insertion
The Safe Surgery Saves Lives approach
Improvement through the Safe Surgery Saves Lives programme
Organization of the guidelines
7
8
10
12
13
15
Section II.
Ten essential objective for safe surgery: Review of the evidence and
recommendations
19
Objective 1: The team will operate on the correct patient at the correct site.
21
The Universal Protocol
Step 1. Verification
Step 2. Marking
Step 3. Time out
Recommendations
Objective 2: The team will use methods known to prevent harm from administration of
anaesthetics, while protecting the patient from pain.
27
Patterns of avoidable morbidity and mortality during anaesthesia
Approaches to improving the safety of anaesthesia
Evidence on monitoring with pulse oximetry and capnography
Expert opinion
Controlled trials
Incident reporting
Inference from data on anaesthesia mortality
Other considerations on oximetry and capnography
Conclusion
Preparation for and delivery of anaesthesia
Facilities
Anaesthesia equipment
Gas supplies in anaesthesia
Monitoring
Ancillary equipment and medications
Infrastructure, supplies and care standards
Recommendations
Objective 3: The team will recognize and effectively prepare for life-threatening loss of airway
or respiratory function.
45
Incidence of difficult and failed airway management
Airway assessment
Thyromental distance
Mallampati classification
Management of the airway
Face-mask ventilation
Supraglottic airway ventilation
Endotrachial intubation
4
Fibre-optic intubation
Aspiration of gastric contents
Recommendations
Objective 4: The team will recognize and effectively prepare for risk of high blood loss. 57
Resuscitation of hypovolaemic patients
Prevention of blood loss
Management of blood loss
Recommendations
Objective 5: The team will avoid inducing an allergic or adverse drug reaction for which the
patient is known to be at significant risk.
63
Types of adverse reactions
Causes of error in delivery of perioperative medications
Recommendations
Objective 6: The team will consistently use methods known to minimize the risk for surgical
site infection.
69
Pathogenesis and microbiology
Prevention and surveillance of surgical site infections
Definitions of surgical site infection
Superficial incisional surgical site infection
Deep incisional surgical site infection
Organspace surgical site infection
Methods of scoring infection
Surveillance of surgical site infections
Inpatients
Post-discharge
Risk factors
Blood glucose and risk of infection
Oxygen tension and temperature in the perioperative period
Presurgical skin disinfection
Alcoholic compounds
Chlorhexidine
Iodophors
Triclosan and chloroxylenol
Octenidine
Special cases for decontamination
Vaginal and uterine surgery
Digestive-tract surgery
Antibiotic prophylaxis
Prophylaxis in children
Subacute bactieral endocarditis prophylaxis in patients undergoing
surgical procedures
Minimizing contamination in the operating room
Guaranteeing sterility of surgical instruments: sterility indicators
Recommendations
Objective 7: The team will prevent inadvertent retention of instruments or sponges in
surgical wounds.
115
General criteria for counting
Sponge count
Sharps count
Instrument count
Documentation of counts
5
Count discrepancies
Methodical wound exploration before closure
Recommendations
Objective 8: The team will secure and accurately identify all surgical specimens.
121
Recommendations
Objective 9: The team will effectively communicate and exchange critical information on the
patient.
123
Team culture and its effects on safety
Patterns of communication breakdown
Reducing communication breakdown during surgery
Use of checklists to improve safety and communication
Record-keeping
Recommendations
Objective 10: Hospitals and public health systems will establish routine surveillance of
surgical capacity, volume and results.
133
Feasibility and implications of measurement
Infrastructure
Economic considerations
Positive incentives
Negative incentives
Case mix and risk adjustment
Current measures in surgery
Volume
Outcome
Capacity
Surgical surveillance: Surgical vital statistics for systems-level evaluation
Basic surgical vital statistics
The number of operating rooms in each country
The number of surgical procedures performed in operating rooms in
each country
The numbers of trained surgeons and trained anaesthesia
professionals in each country
Number of deaths on the day of surgery
Number of in-hospital deaths after surgery
Intermediate surgical vital statistics
Advanced surgical vital statistics
Surgical surveillance: Basic patient measures at hospital and practitioner
levels
Day-of-surgery and postoperative in-hospital mortality rates
Surgical site infections
The Surgical Apgar Score: a simple outcome score for surgery
Findings from international pilot site
Future directions of surgical surveillance
Recommendations
Summary of Recommendations
151
Section III.
153
Section IV.
157
167
7
SECTION I. INTRODUCTION
Confronted with worldwide evidence of substantial public health harm due to
inadequate patient safety, the Fifty-fifth World Health Assembly in 2002 adopted
a resolution (WHA55.18) urging countries to strengthen the safety of health care
and monitoring systems. The resolution also requested that WHO take a lead in
setting global norms and standards and supporting country efforts in preparing
patient safety policies and practices. In May 2004, the Fifty-seventh World
Health Assembly approved the creation of an international alliance to improve
patient safety globally, and the World Alliance for Patient Safety was launched
in October 2004. For the first time, heads of agencies, policy-makers and patient
groups from around the world came together to advance attainment of the goal of
First, do no harm and to reduce the adverse consequences of unsafe health care.
The purpose of the Alliance is to facilitate patient safety policy and practice. It is
concentrating its actions on focused safety campaigns called Global Patient
Safety Challenges, coordinating Patients for Patient Safety, developing a
standard taxonomy, designing tools for research policy and assessment,
identifying solutions for patient safety, and developing reporting and learning
initiatives aimed at producing best practice guidelines. Together these efforts
could save millions of lives by improving basic health care and halting the
diversion of resources from other productive uses.
The Global Patient Safety Challenge, a core element of the Alliance, brings
together the expertise of specialists to improve the safety of care. The area
chosen for the first Challenge, in 20052006, was infection associated with health
care. This campaign established simple, clear standards for hand hygiene, an
educational campaign and WHOs first Guidelines on hand hygiene in health care
(advanced draft) (1).
The problem area chosen for the second Global Patient Safety Challenge, in
20072008, is the safety of surgical care. Preparation of these draft Guidelines on
safe surgery followed the steps recommended by WHO (Table I.1).
Action Taken
Completed
Completed
Completed
Completed
Completed
Completed
Completed
Completed
Completed
In Progress
8
The groundwork for the project began in autumn 2006 and included an
international consultation meeting held in January 2007 attended by experts
from around the world. Following this meeting, expert working groups were
created to coordinate a review of the available scientific evidence, the writing of
the guidelines document and discussion among the authors. Nearly 100
international experts contributed to the document (see end). The guidelines are
being pilot tested in each of the six WHO regionsan essential part of the
Challengeto obtain local information on the resources required to comply with
the recommendations and information on the feasibility, validity, reliability and
costeffectiveness of the interventions.
The problem: Complications of surgical care have become a major cause of death
and disability worldwide.
Data from 56 countries showed that in 2004 the annual volume of major
surgery was an estimated 187 million281 million operations (3), or
approximately one operation annually for every 25 human beings alive. This is a
large and previously unappreciated volume with significant implications for
public health. It is almost double the annual volume of childbirthsin 2006,
there were approximately 136 million births (4)and is at least an order of
magnitude more dangerous. While the rates of death and complications after
surgery are difficult to compare since the case mix is so diverse, in industrialized
countries the rate of major complications has been documented to occur in 316%
of inpatient surgical procedures, and the death rate 0.40.8% (5,6). Nearly half
the adverse events in these studies were determined to be preventable. Studies in
developing countries suggest a death rate of 510% associated with major
surgery (79), and the rate of mortality during general anaesthesia is reported to
be as high as 1 in 150 in parts of sub-Saharan Africa (10). Infections and other
postoperative complications are also a serious concern around the world.
Avoidable surgical complications thus account for a large proportion of
preventable medical injuries and deaths globally. Adverse events have been
estimated to affect 316% of all hospitalized patients (1114), and more than half
of such events are known to be preventable. Despite dramatic improvements in
surgical safety knowledge, at least half of the events occur during surgical care
(5,6). Assuming a 3% perioperative adverse event rate and a 0.5% mortality rate
globally, almost 7 million surgical patients would suffer significant complications
each year, 1 million of whom would die during or immediately after surgery.
Surgical safety has therefore emerged as a significant global public health
concern. Just as public health interventions and educational projects have
dramatically improved maternal and neonatal survival (15), analogous efforts
might improve surgical safety and quality of care.
There are at least four underlying challenges to improving surgical safety.
First, it has not been recognized as a significant public health concern. Because
of the often high expense of surgical care, it is assumed to be of limited relevance
in poor- and middle-income countries; however, the WHO Global burden of
disease report in 2002 (16) showed that a significant proportion of the disability
from disease in the world is due to conditions that are treatable by surgical
intervention. Debas and colleagues (17) estimated that 11% of the 1.5 billion
9
disability-adjusted life years 1 are due to diseases treatable by surgery. An
estimated 63 million people a year undergo surgical treatment for traumatic
injuries, 31 million for malignancies and 10 million for obstetric complications
(18). Problems associated with surgical safety are well recognized in developed
and developing countries alike. In the developing world, the poor state of
infrastructure and equipment, unreliable supplies and quality of medications,
shortcomings in organizational management and infection control, difficulties in
the supply and training of personnel and severe under-financing contribute to the
difficulties.
For more than a century, surgery has been an essential component of public
health. As longevity increases worldwide, its role is increasing rapidly. Lack of
access to basic surgical care remains a major concern in low-income settings, and
WHOs Global Initiative on Emergency and Essential Surgical Care has made
improved access its central mission (19). The parallel requirement for measures
to improve the safety and reliability of surgical interventions, however, has gone
largely unrecognized.
The second underlying problem in improving surgical safety has been a
paucity of basic data. Efforts to reduce maternal and neonatal mortality at
childbirth have relied critically on routine surveillance of mortality rates and
systems of obstetric care, so that successes and failures could be monitored and
recognized. Similar surveillance has been widely lacking for surgical care. The
WHO Patient Safety Programme found that data on surgical volume were
available for only a minority of WHO Member States. The data that were
available were not standardized and varied widely in the types of procedures
recorded. Even countries in which data on surgical procedures are collected
regularly had significant gaps: few reported outpatient surgical procedures, some
did not cover specialty procedures such as gynaecological or orthopaedic
operations, and most did not cover private hospitals. Data from low- and middleincome countries were often extrapolated from regional data or studies published
for other purposes. Virtually none of the countries had reliable information on
inpatient death rates or other measures of adverse outcome.
The third underlying problem in ensuring surgical safety is that existing
safety practices do not appear to be used reliably in any country. Lack of
resources is an issue in low-income settings, but it is not necessarily the most
important one. Surgical site infection, for example, remains one of the most
common causes of serious surgical complications, yet evidence indicates that
proven measuressuch as antibiotic prophylaxis immediately before incision and
confirmation of effective sterilization of instrumentsare inconsistently followed.
This is not because of cost but because of poor systematization. Antibiotics, for
example, are given perioperatively in both rich and poor countries, but in both
they are often administered too early, too late or erratically.
Complications of anaesthesia also remain a substantial cause of death during
surgery globally, despite safety and monitoring standards which have reduced
The disability-adjusted life year (DALY) is an indicator of the time lived with a disability and the
time lost due to premature mortality. It extends the concept of potential years of life lost due to
premature death to include equivalent years of healthy life lost by virtue of being in states of
poor health or disability (World Bank working paper,
http://www.worldbank.org/html/extdr/hnp/hddflash/workp/wp_00068.html, accessed 12
December 2006; and WHO Health Information Systems and Statistics,
http://www.who.int/healthinfo/boddaly/en/index.html, accessed 12 December 2006).
10
the numbers of unnecessary deaths and disabilities in industrialized countries.
Three decades ago, a healthy patient undergoing general anaesthesia had an
estimated 1 in 5000 chance of dying from complications of anaesthesia (20). With
improved knowledge and basic standards of care, the risk has dropped to 1 in 200
000 in the industrialized worlda 40-fold improvement. Unfortunately, the rate
of avoidable death associated with anaesthesia in developing countries is 100
1000 times this rate. Published series showing avoidable anaesthesia mortality
rates of 1:3000 in Zimbabwe (21), 1:1900 in Zambia (22), 1:500 in Malawi (23)
and 1:150 in Togo (10) demonstrate a serious, sustained absence of safe
anaesthesia for surgery.
The fourth underlying problem in improving surgical safety is its complexity.
Even the most straightforward procedures involve dozens of critical steps, each
with an opportunity for failure and the potential for injury to patients, from
identifying the patient and the operative site correctly, to providing appropriate
sterilization of equipment, to following the multiple steps involved in safe
administration of anaesthesia, to orchestrating the operation.
The most critical resource of operating teams is the team itselfthe surgeons,
anaesthesia professionals, nurses and others. A team that works effectively
together to use its knowledge and abilities on behalf of the surgical patient can
avert a considerable proportion of life-threatening complications. Yet, operatingroom personnel have had little guidance or structure for fostering effective
teamwork and thus minimizing the risks for surgical safety.
The aim of the Safe Surgery Saves Lives programme is to remedy these
problems.
The Safe Surgery Saves Lives Challenge: Identifying solutions
The goal of the Safe Surgery Saves Lives Challenge is to improve the safety of
surgical care around the world by defining a core set of safety standards that can
be appied in all countries and settings. Working groups of international experts
were created to review the literature and the experiences of clinicians around the
world and to achieve consensus on safety practice in four topic areas: teamwork,
anaesthesia, prevention of surgical site infection and measurement of surgical
services. Contributors with expertise in surgery, anaesthesia, nursing, infectious
diseases, epidemiology, biomedical engineering, health systems, quality
improvement and other related fields, as well as patients and patient safety
groups, were recruited from each of the WHO regions; they themselves solicited
further input from practitioners and other stakeholders worldwide.
At the first consultation in January 2007, difficulties in improving surgical
safety were identified and reviewed. Surgery was defined as any procedure
occurring in the operating room involving the incision, excision, manipulation or
suturing of tissue that usually requires regional or general anaesthesia or
profound sedation to control pain. It was recognized that, in surgery, there is no
single remedy that would change safety. Safety in surgery requires the reliable
execution of multiple necessary steps in care, not just by the surgeon but by a
team of health-care professionals working in concert for the benefit of the patient.
It was recognized that reliability in other medical fieldsfor example,
obstetrics and medication administrationhas been improved by identifying the
basic components of care to be provided and by standardizing routines with tools
such as checklists. Three examples of particular relevance are described below.
11
Anaesthesia experts reviewed lessons from aviation, nuclear power and other
industries known as high-reliability organizations, which have five identifiable
qualities that define their performance: preoccupation with failure, reluctance to
simplify interpretations, sensitivity to operation, commitment to resilience and
deference to expertise (24). Leaders in anaesthesia therefore began by
acknowledging the persistence of human error. Researchers studied individual
incidents in detail and enumerated a list of contributory factors, which included
inadequate experience, inadequate familiarity with equipment, poor
communication among team members, haste, inattention, fatigue and poor
equipment design (25). Through national professional societies, first in the
United States and then across Europe and in other industrialized countries, a
system of improved anaesthesia care was designed. The specific standards of
practice mandate that anaesthetists never leave a patient unattended and
always monitor vital signs in a prescribed minimum regimen. Changes were
made in technological and engineering design, and manufacturing standards for
anaesthesia equipment were established with fallible human beings in mind. For
example, the sequence and size of dials were standardized, as was the direction
for turning them on and off; locks were incorporated to prevent accidental
administration of more than one anaesthetic gas; controls were changed so that
the concentration of oxygen delivered could not be reduced below its
concentration in room air. Most recently, pulse oximeters and capnographs have
been designated as essential instruments for monitoring anaesthesia.
Since these changes, deaths due to misconnection of the breathing system or
intubating the oesophagus rather than the trachea have become virtually
unknown instead of being common causes of death during anaesthesia. In a
single decade, the overall death rate associated with general anaesthesia in
industrialized nations dropped by more than 95%from one in 5000 cases to one
in 200 000 (26).
The time out or surgical pause : In surgery, there are few examples of
systematic improvements in safety; however, over the past 5 years in the United
States and other industrialized countries, a time out or surgical pause has been
introduced as a standard component of surgical care (27). This is a brief, less
than 1-min pause in operating-room activity immediately before incision, at
which time all members of the operating teamsurgeons, anaesthesia
professionals, nurses and anyone else involvedverbally confirm the identity of
the patient, the operative site and the procedure to be performed. It is a means of
ensuring clear communication among team members and avoiding wrong-site or
12
wrong-patient errors. It has been made mandatory in the United States and a
few other countries.
Further experiments with this procedure have resulted in what has been
called an extended pause, during which more protective measures are taken
(28). This involves confirmation not only the identity of the patient and the
surgical site, but also discussion by team members of the critical details of the
operation to be performed. Open communication and improved teamwork are
encouraged (29,30). In studies in single institutions, the extended pause has been
shown to improve safety and is associated with improved choice and timing of
prophylactic antibiotics and appropriate maintenance of intraoperative
temperature and glycaemia (28,31).
Use of a checklist for central line insertion: A research team at Johns Hopkins
(2)
(3)
(4)
by testing the checklist and surveillance tools at pilot sites in all WHO
regions and then disseminating the checklist to hospitals worldwide.
13
The WHO Guidelines for safe surgery are central to this effort. The working
groups of the Safe Surgery programme considered a range of potential standards,
evaluated the evidence for their inclusion, estimated their possible impact and
designed measures to assess their effects on performance and safety. The
programme also designed a checklist that can be used by practitioners interested
in promoting safety and improving the quality of surgical services. It reinforces
established safety practices and ensures beneficial preoperative, intraoperative
and postoperative steps are undertaken in a timely and efficient way. Many of
the steps are already accepted as routine practice in facilities around the world.
The aim is not to prescribe a single manner of implementation or to create a
regulatory tool. Rather, by introducing key safety elements into the operating
routine, teams could maximize the likelihood of the best outcome for all surgical
patients without placing an undue burden on the system or the providers.
In nearly all settings, the standards will represent changes in some routines.
The standards could, however, result in tangible life-saving improvements in
care in all environments, from the richest to the poorest. The Second Global
Patient Safety Challenge is based on the recognition that every country can
improve the safety of its surgical care.
Improvement through the Safe Surgery Saves Lives programme
The established framework for safe intraoperative care in hospitals involves a
routine sequence of eventspreoperative evaluation of patients, surgical
intervention and preparation for appropriate postoperative careeach with
specific risks that can be mitigated (Table I.2). In the preoperative phase,
obtaining informed consent, confirming patient identity and operative site and
the procedure to be undertaken, checking the integrity of the anaesthetic
machine and the availability of emergency medications, and adequate
preparation for intraoperative events are all amenable to intervention. During
the operation, appropriate and judicious use of antibiotics, availability of
essential imaging, appropriate patient monitoring, efficient teamwork, competent
anaesthetic and surgical judgements, meticulous surgical technique and good
communication among surgeons, anaesthesia professionals and nurses are all
necessary to ensure a good outcome. After the operation, a clear plan of care, an
understanding of intraoperative events and a commitment to high-quality
monitoring may all improve the surgical system, thereby promoting patient
safety and improving outcomes. There is also a recognized need for trained
personnel and functioning resources, such as adequate lighting and sterilization
equipment. Finally, safe surgery requires ongoing quality assurance and
monitoring.
14
Table I.2 The nature of the challenge: Teamwork, safe anaesthesia and
prevention of surgical site infection are fundamental to improving the safety of
surgery and saving lives. Basic issues of infrastructure must be considered and of
the ability to monitor and evaluate any instituted changes must be addressed.
Surgical Resources and Environment
Trained personnel, clean water, consistent light source, consistent suction, supplemental oxygen, functioning
surgical equipment and sterile instruments
Prevention of Surgical Site
Infection
Hand washing
Appropriate and judicious use of
antibiotics
Antiseptic skin preparation
Atraumatic wound care
Instrument decontamination and
sterility
Safe Anaesthesia
Presence of a trained anaesthesia
professional
Anaesthesia machine and medication
safety check
Pulse oximetry
Heart rate monitoring
Blood pressure monitoring
Temperature monitoring
Not all these factors can be addressed within the context of the Safe Surgery
programme. The economic and physical resources of national health systems are
limited by many factors, including economic development status. The Safe
Surgery Saves Lives Challenge is a 2-year initiative, and, early in the
investigative phase, the programme team determined that it would be unable to
address the issues of resources and infrastructure shortfalls given the budget and
time frame of this project. Similarly, although human resources are vital for
health delivery and for safe care, improvement will require so much investment
in education, infrastructure and training that success is unlikely in the near
future. In addition, the significant work performed by many health-care workers
who lack credentials but fill an important, even vital need, particularly in
resource-limited settings, should not be minimized; but there is no clear
consensus on what constitutes appropriate training, how much training is
enough and how to measure competence. The absence of such basic information
makes it exceedingly difficult to set standards for training and credentialing and
ultimately leaves it to governments and professional societies to determine how
best to approach these issues, given their resources and needs.
In view of the limitations for addressing infrastructure and human resources,
the expert working groups determined that the most effective initial intervention
would be to establish universal standards for safety for existing surgical teams
and their work in the operating room. These standards would be operationalized
by wide implementation of a checklist and the creation of basic, standardized
measures of surgical services. Universal features, strategies and workflow
patterns of the perioperative period are critical for care, prone to failure and
amenable to simple improvements.
15
The aim of the working groups was to identify potential standards for
improvements in four areas: safe surgical teams, by promoting communication
among team members to ensure that each preparatory step is accomplished in a
timely and adequate fashion with an emphasis on teamwork; safe anaesthesia,
by appropriate patient monitoring and advance preparation to identify
potentially lethal anaesthetic or resuscitation problems before they cause
irreversible harm; prevention of surgical site infection, through antisepsis and
control of contamination at all levels of patient care; and measurement of
surgical services, by creating public health metrics to measure provision and
basic outcomes of surgical care.
The Safe Surgery Saves Lives Challenge was further guided by three
principles. The first is simplicity. An exhaustive list of standards and guidelines
might create a package that would improve patient safety, but such
comprehensiveness would be difficult to implement and convey and would
probably face significant resistance. The appeal of simplicity in this setting
cannot be overstated. Uncomplicated measures will be the easiest to institute
and can have profound effects in a variety of settings.
The second principle is wide applicability. Focusing on a specific resource
milieu would reduce the number of issues (e.g. minimum equipment standards
for resource-poor settings), but the goal of the challenge is to reach all
environments and settings, from resource rich to resource poor, so that all
Member States can be involved. Furthermore, regular failures occur in every
setting and environment and are amenable to common solutions.
The third is measurability. Measurement of impact is a key component of the
Second Challenge. Meaningful metrics must be identified, even if they relate only
to surrogate processes, and they must be reasonable and quantifiable by
practitioners in all contexts.
If the three principles of simplicity, wide applicability and measurability are
followed, the goal of successful implementation will be feasible.
Organization of the guidelines
The guidelines are designed to meet these principles and are organized in
three steps.
First, the specific objectives for safe surgical care are enumerated. Secondly,
the findings from reviews of evidence on and experience with approaches to
meeting each of the objectives are described. Lastly, potentially beneficial
practices are classified into three categories on the basis of clinical evidence or
expert opinion as to their ability to reduce the likelihood of serious, avoidable
surgical harm and whether adherence is unlikely to introduce injury or
unmanageable cost:
While the review was relatively comprehensive, it did not make clear how the
findings were to be operationalized. Therefore, at the end of the review for each
objective and in order to provide simple means for practitioners to ensure and
16
improve standards of safety, we focused on the highly recommended practices
and used them to construct two products: a WHO safe surgery checklist and a
set of recommended surgical vital statistics for measurement.
These guidelines are, as noted, a first edition, and are undergoing final review
and testing at pilot sites around the world. Nonetheless, there is wide recognition
that every country can improve the safety of its surgical care and that this is a
critical matter of public health, affecting hundreds of millions of people
worldwide each year. By creating a culture of safety, the World Alliance for
Patient Safety and WHO are seeking to promote practice standards that reduce
injuries and save lives.
References
1. World Health Organization. WHO guidelines on hand hygene in health care
(advanced draft). Geneva, World Health Organization, 2003.
2. World Health Organization. Guidelines for WHO guidelines. Geneva, Global
Programme on Evidence for Health Policy, 2003.
3. Weiser T, et al. An estimation of the global volume of surgery. Lancet (accepted for
publication).
4. Population Reference Bureau. 2006 world population data sheet.
http://www.prb.org/pdf06/06WorldDataSheet.pdf (accessed 12 April 2007).
2006.
5. Gawande AA, et al. The incidence and nature of surgical adverse events in Colorado
and Utah in 1992. Surgery, 1999, 126:6675.
6. Kable AK, Gibberd RW, Spigelman AD. Adverse events in surgical patients in
Australia. International Journal of Quality in Health Care, 2002, 14:26976.
7. Bickler SW, Sanno-Duanda B. Epidemiology of paediatric surgical admissions to a
government referral hospital in the Gambia. Bulletin of the World Health
Organization, 2000, 78:13306.
8. Yii MK, Ng KJ. Risk-adjusted surgical audit with the POSSUM scoring system in a
developing country. British Journal of Surgery, 2002, 89:1103.
9. McConkey SJ. Case series of acute abdominal surgery in rural Sierra Leone. World
Journal of Surgery, 2002, 26:50913.
10. Ouro-Bang'na Maman AF, et al. Deaths associated with anaesthesia in Togo, West
Africa. Tropical Doctor, 2005, 35:2202.
11. Brennan TA, et al. Incidence of adverse events and negligence in hospitalized
patients. Results of the Harvard Medical Practice Study I. New England Journal of
Medicine, 1991, 324:3706.
12. Wilson RM, et al. The Quality in Australian Health Care Study. Medical Journal of
Australia, 1995, 163:458471.
13. Leape LL, et al. The nature of adverse events in hospitalized patientsresults of the
Harvard Medical Practice Study II. New England Journal of Medicine, 1991,
324:37784.
14. United Kingdom Department of Health. An organization with a memory. London,
2000.
15. Ronsmans C, et al. Maternal mortality: who, where, and why. Lancet, 2006,
368:1189200.
16. World Health Organization. Global burden of disease estimates, 2002. Geneva, 2002.
http://www.who.int/healthinfo/bodgbd2002/en/index.html (accessed 20 October 2006).
17
17. Debas H, et al. Surgery. In: Disease control priorities in developing countries, 2nd ed.
Washington DC, International Bank for Reconstruction and Development and The
World Bank Disease Control Priorities Project, 2006.
18. World Health Organization. World Alliance for Patient Safety: forward programme
20062007. Geneva, 2006.
19. World Health Organization. Global initiative for emergency and essential surgical
care (GIEESC). Geneva. http://www.who.int/surgery (accessed 20 March 2008).
20. Leape LL. Error in medicine. Journal of the American Medical Association, 1994,
272:18517.
21. McKenzie AG. Mortality associated with anaesthesia at Zimbabwean teaching
hospitals. South African Medical Journal, 1996, 86:33842.
22. Heywood AJ, Wilson IH, Sinclair JR. Perioperative mortality in Zambia. Annals of
the Royal College of Surgeons of England, 1989, 71:3548.
23. Hansen D, Gausi SC, Merikebu M. Anaesthesia in Malawi: complications and deaths.
Tropical Doctor, 2000, 30:1469.
24. Reason J. Human error. Cambridge, Cambridge University Press, 1992.
25. Cooper JB, et al. Preventable anesthesia mishaps: a study of human factors.
Anesthesiology, 1978, 49:399406.
26. Pierce EC. The 34th Rovenstine Lecture: 40 years behind the masksafety revisited.
Anesthesiology, 1996, 84:96575.
27. Joint Commission. Universal protocol for preventing wrong site, wrong procedure,
2003.
wrong
person
surgery.
http://www.jointcommission.org/PatientSafety/UniversalProtocol/
(accessed
15
February 2007).
28. Makary MA, et al. Operating room briefings: working on the same page. Joint
Commission Journal on Quality and Patient Safety, 2006, 32:3515.
29. Helmreich RL, et al. Preliminary results from the evaluation of cockpit resource
management training: performance ratings of flightcrews. Aviation, Space and
Environmental Medicine, 1990, 61:5769.
30. Pronovost PJ, et al. Creating high reliability in health care organizations. Health
Services Research, 2006, 41:1599617.
31. Altpeter T, et al. Expanded surgical time out: a key to real-time data collection and
quality improvement. Journal of the American College of Surgeons, 2007, 204:527
32.
32. Pronovost P, et al. An intervention to decrease catheter-related bloodstream
infections in the ICU. New England Journal of Medicine, 2006, 355:272532.
33. Hales BM, Pronovost PJ. The checklista tool for error management and performance
improvement. Journal of Critical Care, 2006, 21:2315.
18
19
SECTION II. TEN ESSENTIAL OBJECTIVES FOR SAFE SURGERY: REVIEW
OF THE EVIDENCE AND RECOMMENDATIONS
Surgical care is complex and involves dozens of steps which must be
optimized for individual patients. In order to minimize unnecessary loss of life
and serious complications, operative teams have 10 basic, essential objectives in
any surgical case, which the WHO safe surgery guidelines support.
1. The team will operate on the correct patient at the correct site.
2. The team will use methods known to prevent harm from administration
of anaesthetics, while protecting the patient from pain.
3. The team will recognize and effectively prepare for life-threatening loss
of airway or respiratory function.
4. The team will recognize and effectively prepare for risk of high blood
loss.
5. The team will avoid inducing an allergic or adverse drug reaction for
which the patient is known to be at significant risk.
6. The team will consistently use methods known to minimize the risk for
surgical site infection.
7. The team will prevent inadvertent retention of instruments or sponges
in surgical wounds.
8. The team will secure and accurately identify all surgical specimens.
9. The team will effectively communicate and exchange critical information
for the safe conduct of the operation.
10. Hospitals and public health systems will establish routine surveillance
of surgical capacity, volume and results.
20
21
Objective 1: The team will operate on the correct patient at the correct site.
While wrong-site or wrong-patient surgery is rare, even a single incident can
result in considerable harm to the patient. There are recurrent and persistent
reports of wrong-site operations on limbs and the brain and of patients who have
had the wrong kidney, adrenal gland, breast or other organ removed. The
attention that such events invariably attract in the media undermines public
confidence in health-care systems and in the physicians who provide care.
It has been estimated that wrong-site and wrong-patient surgery occurs in
about 1 in 50 000100 000 procedures in the United States, equivalent to 1500
2500 incidents each year (1,2). In an analysis of sentinel events reported between
1995 and 2006, the Joint Commission for Accreditation of Health Organizations
found that just over 13% of reported adverse events were due to wrong-site
surgery (3). An analysis of 126 cases of wrong-site or wrong-patient surgery in
2005 revealed that 76% were performed on the wrong site, 13% on the wrong
patient and 11% involved the wrong procedure. The literature supports the
supposition that wrong-site surgery is more common in certain fields,
particularly orthopaedic surgery. In a survey of 1050 hand surgeons, 21%
reported having performed wrong-site surgery at least once in their careers (4).
An analysis of malpractice insurance claims following orthopaedic surgery
showed that 68% were for wrong-site surgery (5).
Wrong-site surgery is more likely to occur in procedures associated with
bilaterality. Failures in communication between team members and problems
with leadership were the major contributory factors in the report of the Joint
Commission for Accreditation of Health Organizations (3). In a separate analysis
of 13 non-spine wrong-site procedures, Kwaan et al. (1) showed that four cases
were due to errors in the operating schedule, and in 66% of cases in which the
consent form was reviewed the site or side was not specified. Factors such as the
absence of radiographic images and wrong site labelling on the images play a
causative role in faulty orthopaedic and spinal procedures (1,2). Organizational
culture, interpersonal dynamics and steep hierarchical structures in the
operating room contribute to error by creating an environment in which persons
who could prevent an error are reluctant to speak up (6). Thus, systems failures
account for a large number of wrong-site events. Accurate patient identification
and labelling, patient involvement in preoperative planning, informed consent,
better communication among team members and improved teamwork and
protocols could all reduce these types of error. Elimination of wrong site, wrong
patient and wrong procedure errors has been a goal of the Joint Commission
since 2000 (7).
Wrong-site surgery received prominent attention in the early 1990s, and
surgeons (in particular orthopaedists) and professional organizations made
attempts to address the issue. The Canadian Orthopaedic Association
recommended marking the incision site with a permanent marker in 1994 (8).
Professional orthopaedic organizations took this up as a matter of policy, and in
1998 the American Academy of Orthopaedic Surgeons started a campaign called
Sign Your Site. That same year the Joint Commission gathered information on
sentinel events of wrong-site surgery and sought strategies to address the issue.
In 2003, the Joint Commission formulated and mandated use of a universal
protocol for the prevention of wrong-site, wrong-patient and wrong-procedure
errors (9) which has been adopted by many professional organizations, including
the American College of Surgeons (10).
22
Step 1. Verification: This consists of verifying the correct patient, site and
procedure at every stage from the time a decision is made to operate to the time
the patient undergoes the operation. This should be done:
any time the responsibility for care of the patient is transferred to another
person; and
before the patient leaves the preoperative area or enters the procedure or
surgical room.
The step is undertaken insofar as possible with the patient involved, awake
and aware. Verification is done by labelling and identifying the patient and
during the consent process; the site, laterality and procedure are confirmed by
checking the patients records and radiographs. This is an active process that
must include all members of the team involved in the patients care. When many
team members are involved in verification, each check should be performed
independently. Team members must also be aware, however, that the
involvement of multiple caregivers in verification can make the task appear
onerous and could lead to violations of the protocol. Adherence to the verification
procedure can be facilitated by the use of reminders in the form of checklists or
systematic protocols (11).
Step 2. Marking: The Universal Protocol states that the site or sites to be
operated on must be marked. This is particularly important in case of laterality,
multiple structures (e.g. fingers, toes, ribs) and multiple levels (e.g. vertebral
column). The protocol stipulates that marking must be:
23
completed, to the extent possible, while the patient is alert and awake, as
the patients involvement is important.
Step 3. Time out: The time out or surgical pause is a brief pause before the
incision to confirm the patient, the procedure and the site of operation. It is also
an opportunity to ensure that the patient is correctly positioned and that any
necessary implants or special equipment are available. The Joint Commission
stipulates that all team members be actively involved in this process. Any
concerns or inconsistencies must be clarified at this stage. The checks during the
time out must be documented, potentially in the form of a checklist, but the
Universal Protocol leaves the design and delivery to individual organizations.
The time out also serves to foster communication among team members.
The Australian Commission on Safety and Quality in Healthcare uses a fivestep process similar to the Universal Protocol to prevent wrong-site surgery (17):
Step 1: Check that the consent form or procedure request form is correct.
Step 2: Mark the site for the surgery or other invasive procedure.
Step 3: Confirm identification with the patient.
Step 4: Take a team time out in the operating theatre, treatment or
examination area.
Step 5: Ensure appropriate and available diagnostic images.
Consent is part of both protocols. It is the first step in the Australian protocol
and is included as critical documentation in the Universal Protocol in the United
States. While consent is being obtained, the patient must be awake and alert and
have the capacity to understand the details and implications of the procedure.
Consent must be obtained in a language that the patient understands or through
an interpreter. It should include a clear statement of the procedure to be
performed and the site of operation, including laterality or level (18). The consent
protocol can, however, be waived in emergency cases with threat to life or limb.
Preoperative verification protocols have only recently been introduced in
many parts of the world. Evidence of their efficacy in reducing the incidence of
wrong-site surgery is lacking, although preliminary data suggest that such
actions are effective. The Orange County Kaiser Permanente organization in the
United States found a reduction in the incidence of wrong-site surgery after the
introduction of a checklist (19). Similarly, there has been a reduction in wrongsite surgery in Western Australia, from 10 reported cases in 20042005 to four in
20052006 (20). A study by Makary et al. at Johns Hopkins hospital in the
United States showed that team awareness of the correct site of operation
increased with use of a checklist and briefing (21). While evidence is still being
24
gathered, protocols for ensuring correct patient and procedure are well
established, inexpensive, recommended by many professional societies and, if
followed with care and consideration, promote safe surgical practice.
Recommendations
Highly recommended:
A team member should confirm that the patient has given informed
consent for the procedure and should confirm the correct site and
procedure with the patient.
The surgeon performing the operation should mark the site of surgery in
cases involving laterality or multiple structures or levels (e.g. a finger, toe,
skin lesion, vertebra). Both the anaesthesia professional and the nurse
should check the site to confirm that it has been marked by the surgeon
performing the operation and reconcile the mark with the information in
the patients records. The mark should be unambiguous, clearly visible
and usually made with a permanent marker so that it does not come off
during site preparation. The type of mark can be determined locally
(signing, initialling or placing an arrow at the site). A cross or X should
be avoided, however, as this has been misinterpreted to mean that the site
is the one not to be operated on.
As a final safety check, the operating team should collectively verify the
correct patient, site and procedure during a time out or pause
immediately before skin incision. The surgeon should state out loud the
patients name, the operation to be performed, and the side and site of
surgery. The nurse and anaesthesia professional should confirm that the
information is correct.
References
1. Kwaan MR, et al. Incidence, patterns, and prevention of wrong-site surgery. Archives
of Surgery, 2006, 141:3538.
2. Seiden SC, Barach P. Wrong-side/wrong-site, wrong-procedure, and wrong-patient
adverse events: Are they preventable? Archives of Surgery, 2006, 141:9319.
3. Joint
Commission.
Sentinel
event
statisticsDecember
31,
2006.
http://www.jointcommission.org/SentinelEvents/Statistics (accessed 5 May 2007).
Sentinel
events
alert5th
December
2001.
4. Joint
Commission.
http://www.jointcommission.org/SentinelEvents/sentineleventalert/sea_24.htm
(accessed 3 May 2007).
5. Cowell HR. Wrong-site surgery. Journal of Bone and Joint Surgery (American), 1998,
80:463.
25
6. Dyer C. Doctors go on trial for manslaughter after removing wrong kidney. British
Medical Journal, 2002, 324:1476.
7. Joint
Commission.
National
patient
safety
goals.
http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/08_hap_n
psgs.htm (accessed 25 January 2008).
8. Canale ST. Wrong-site surgery: a preventable complication. Clinical Orthopaedics
and Related Research, 2005, 433:269.
9. Joint Commission. Universal protocol for preventing wrong site, wrong procedure,
wrong
person
surgery.
http://www.jointcommission.org/PatientSafety/UniversalProtocol/
(accessed
15
February 2007).
10. American College of Surgeons. Statement on ensuring correct patient, correct site,
and correct procedure surgery. Bulletin of the American College of Surgeons, 2002,
87:12.
11. Michaels RK, et al. Achieving the National Quality Forum's 'never events': prevention
of wrong site, wrong procedure, and wrong patient operations. Annals of Surgery,
2007, 245:52632.
12. National Patient Safety Agency and Royal College of Surgeons of England. Patient
2005.
briefingcorrect
site
surgery.
http://www.rcseng.ac.uk/publications/docs/patient_briefing.html/?searchterm=patient
%20safety (accessed 25 January 2008).
13. American Academy of Orthopaedic Surgery. AAOS advisory statement on wrong-site
surgery. http://www.aaos.org/about/papers/advistmt/1015.asp (accessed 25 January
2008).
14. Giles SJ, et al. Experience of wrong site surgery and surgical marking practices
among clinicians in the UK. Quality and Safety in Health Care, 2006, 15:3638.
15. Joint Commission. Speak up: help avoid mistakes in your surgery. 2007.
http://www.jointcommission.org/patientsafety/speakup/speak_up_ws.htm (accessed 5
May 2007).
16. National Patient Safety Agency. Correct site surgerymaking your surgery safer.
http://www.npsa.nhs.uk/site/media/documents/884_0186FEB05_01_26.pdf (accessed 3
May 2007).
17. Australian Commission on Safety and Quality in Healthcare. Ensuring correct
patient,
correct
site,
correct
procedure.
http://www.safetyandquality.gov.au/internet/safety/publishing.nsf/content/formerpubs-archive-correct (accessed 23 August 2007).
18. Department of Health, United Kingdom. Reference guide to consent for examination
or
treatment.
http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyand
guidance/dh_4006757 (accessed 28 May 2007).
26
27
Objective 2: The team will use methods known to prevent harm from
administration of anaesthetics, while protecting the patient from pain.
In developed countries, anaesthesia is associated with low risks for serious
morbidity and mortality. Current estimates of avoidable mortality associated
with anaesthesia in Australia and Europe vary from about 1:10 000 to about
1:185 000 (14). The rate of mortality attributable solely to anaesthesia in
healthy patients undergoing minor surgical procedures is likely to be at the lower
end of this range. The higher estimates tend to reflect mortality to which
anaesthesia is thought to have contributed, often in patients with significant
comorbidity who are undergoing major surgery. There are, however, few reliable
data to determine the true rate of mortality associated with anaesthesia. A rate
of 1 in 79 509 was reported in a review in Australia between 1997 and 1999 (5).
In a subsequent review from the same source covering the years 20002002, the
reported rate was 1 in 56 000, the revised estimate being based on improved data
for the denominator attributable to the introduction of anaesthesia-specific
coding (6). These Australian reports probably provide the best estimates of
mortality associated with anaesthesia available for any nation in the world;
however, the discrepancy between the rates in the two reports indicates that the
mortality rate for the 1990s was unclear, and it remains so for most of the world.
Lagasse (7) reviewed data on mortality during the last four decades of the
twentieth century and attributed the wide variation in rates to lack of
standardization of definitions. His contention that mortality had not improved
was strongly challenged by Cooper and Gaba (8), who argued that there is
credible evidence that mortality has decreased substantially among relatively
healthy patients undergoing elective procedures, which was the initial aim of
patient safety efforts in anaesthesia.
Estimation of mortality due to anaesthesia is problematic: most reporting is
voluntary, the denominator is seldom a reliable figure, sedation is not routinely
captured, the case mix to which the figures are applied is usually unknown, and
there is no agreed definition of anaesthetic mortality. Even when clearly defined,
it may be difficult to separate it from causes related to the operation and the
patients underlying condition. Nevertheless, there is good reason to believe that
anaesthesia-related risks in the developed world have decreased significantly
over the past two decades due to improvements in training, equipment and
medications and the introduction of standards and protocols. Mandatory
monitoring standards, in particular pulse oximetry and capnography, are
considered particularly important (9,10).
Unfortunately, the avoidable anaesthesia-associated mortality in developing
countries has been estimated at 1001000 times the rate reported in developed
countries. In published series, avoidable mortality associated with anaesthesia
was as high as 1:3000 in Zimbabwe (11), 1:1900 in Zambia (12), 1:500 in Malawi
(13) and 1:150 in Togo (14). The methods used in these studies are comparable,
and they demonstrate a serious, sustained lack of safe anaesthesia for surgery.
Patterns of avoidable morbidity and mortality during anaesthesia
Mortality associated with anaesthesia, particularly in the developing world, is
primarily related to two causes: airway problems and anaesthesia in the presence
of hypovolaemia. A substantial proportion of anaesthesia-related deaths in the
developed world occur in obstetric patients (1517); reports from Nigeria (18) and
Malawi (19) demonstrate that these patients account for 50% of the anaesthesia-
28
related deaths in developing countries. These studies also indicate that poor
technique and lack of training, supervision and monitoring contribute to the high
mortality. The potential for professionals to learn lessons about avoidable deaths
is limited in many hospitals, as few such events are recorded or formally
discussed.
These unacceptably high figures are indicative of a deteriorating situation.
Information from Uganda in 2006 (20) illustrates the constraints anaesthesia
providers face, including shortages of the most basic facilities, equipment and
medications and few physician anaesthetists (13 for 27 million people, compared
with 12 000 for 64 million in the United Kingdom); most anaesthesia is thus
performed by non-physicians. This situation is similar to that in other parts of
Africa (2123). Although the situation varies widely throughout the world,
anaesthesia services in many countries are extremely poor, particularly in rural
areas (24,25). For the most part, deficiencies go unrecorded, as there are few
systematic reviews of anaesthetic conditions and practice.
Perioperative mortality is usually due to a combination of factors related to
patients (and their underlying medical condition), surgery, anaesthesia and
management. In order to improve the safety of patients undergoing surgery,
anaesthesia services must be made safer, especially in developing countries. This
will require investment in the form of improved training of anaesthesia
professionals, safer facilities, functioning equipment, adequate drug supplies and
mandatory pulse oximetry. International standards play an important role in
guiding the development of anaesthesia services and should be adopted by
ministries of health and local professional societies.
In order that no patient be harmed by anaesthesia, several goals must be met:
29
detailed medical standards of practice (26). They stimulated the American
Society of Anesthesiologists to adopt their Standards for Basic Intraoperative
Monitoring in 1986. This initiative encouraged a cascade of standards, guidelines
and protocols by professional anaesthesiology groups and societies around the
world.
In 1989, the International Task Force on Anaesthesia Safety was established,
comprising leaders in anaesthesia patient safety in nine countries (27). After 2
years of extensive work, the Task Force published the first International
standards for a safe practice of anaesthesia (28). The document consisted of four
printed pages and contained an outline of both general standards for the
profession and practice of anaesthesiology and specific standards for perianaesthetic care and monitoring. Because of the variation in resources available
in different locations around the world, the standards for equipment required for
peri-anaesthetic care and monitoring were classified into three levels: basic,
intermediate and optimal, to correlate realistically with available local resources.
The essential care and monitoring concepts were universal and applicable
everywhere, from the most isolated, resource-challenged locations in the
developing world to the most economically and technologically advanced capitals.
Ability to implement the concepts differed greatly, however. One focus was to
help provide more anaesthetists in disadvantaged areas and to secure resources
for improving anaesthesia quality and safety. The World Federation of Societies
of Anesthesiologists formally adopted these international standards at its
congress in The Hague in June 1992 and recommended them to all its member
societies. The International standards for a safe practice of anaesthesia and 10
supporting documents were published as Supplement 7 to the European Journal
of Anaesthesiology in January 1993 (28).
The work of the International Task Force underpins much of the current
work in anaesthesia safety. At the most recent meeting of the World Federation
of Societies of Anaesthesiologists, the 1992 standards were revised and updated
and subsequently endorsed by the General Assembly during the 14th World
Congress of Anaesthesiologists in Cape Town, South Africa, on 7 March, 2008
(29). The older standards had not, however, been actively promoted or endorsed
globally. If the safety of anaesthetic services is to be improved, wide adoption of
the standards is imperative. The main addition to the previous international
standards is the requirement for pulse oximetry as an essential component of
patient monitoring. Pulse oximetry is used almost universally in industrialized
countries during the administration of anaesthesia. While strong, unequivocal
evidence from a randomized clinical trial is lacking, few anaesthesia providers
would willingly do without this device. As this represents a departure from the
previous standards and imposes a potentially substantial cost on facilities, a full
review of the evidence for this recommendation is warranted.
Evidence on monitoring with pulse oximetry and capnography
There is no evidence from randomized controlled trials that pulse oximetry or
capnography has had an important effect on the outcome of anaesthesia (30).
Evaluation of any safety intervention, however, requires consideration not only of
the frequency of the adverse events that might be prevented but also of their
potential severity. The prevention of an event may warrant considerable
investment if it is serious, even if it is infrequent. Furthermore, prevention is
more readily justified if the risks associated with the preventive measures are
30
low. The death of, or brain damage to, an otherwise healthy person due to an
entirely preventable anaesthetic mishap, such as ventilator disconnection or
oesophageal intubation, is catastrophic; the risks associated with pulse oximetry
and capnography are exceedingly low.
Expert opinion: The anaesthesia community has led health care in the pursuit of
patient safety (8). A prime example of systems improvement is the adoption of
pulse oximetry and capnography as standard care in anaesthesia. In many
countries today, there is a generation of anaesthetists who have never practised
without pulse oximetry or capnography, and routine use of these techniques is
mandated in the standards or guidelines of professional anaesthesia
organizations in a number of countries (e.g. the Australian and New Zealand
College of Anaesthetists, the Hong Kong College of Anaesthetists, the Malaysian
Society of Anaesthesiologists, the Nigerian Society of Anaesthetists, the
Association of Anaesthetists of Great Britain and Ireland, the American Society
of Anaesthesiologists in the United States and the Uruguay Society of
Anaesthesiologists). It is likely that pulse oximetry and capnography are used in
over 99% of general and regional anaesthetics in the United States and Canada,
much of Europe, Australia, New Zealand and many other countries. This level of
adoption reflects an almost universal conviction on the part of anaesthesia
providers that these techniques contribute substantially to the safe provision of
anaesthesia. The fact that the standards in many different countries are almost
identical amounts to an extended Delphi process for establishing consensus
among experts. The weight of international expert opinion overwhelmingly
supports use of these techniques for the safety of anaesthesia.
Compliance with best-practice guidelines for health care in general is
sporadic and inconsistent, even in highly developed systems of health delivery
(31); however, compliance with standards, guidelines and recommendations for
the use of pulse oximetry and capnography in the developed world is virtually
100%. They have not only been mandated by authorities in the anaesthetic
profession, they have also been embraced whole-heartedly and unequivocally by
virtually every practising anaesthetist who has access to them (32). Informal
surveys indicate that anaesthetists in many parts of the world cancel elective
cases rather than proceed in the absence of either of these monitors. Widespread
use of pulse oximetry is the primary goal of the Global Oximetry project, a
collaboration among several professional societies of anaesthesiology and
industry to promote widespread adoption of pulse oximetry, with particular
emphasis in developing countries. The project includes evaluation of current
oximeter design and cost, the educational requirements for effective use of pulse
oximeters and barriers to their widespread adoption in appropriate settings (33).
The adoption of pulse oximetry by anaesthetists has been an unusual, strikingly
successful example of standardization of practice in health care.
of which were deemed ineligible for inclusion because they lacked a control group
or information on relevant postoperative outcomes. They concluded:
The studies confirmed that pulse oximetry can detect hypoxaemia
and related events. However, we have found no evidence that pulse
oximetry affects the outcome of anaesthesia. The conflicting
31
subjective and objective results of the studies, despite an intense,
methodical collection of data from a relatively large population,
indicate that the value of perioperative monitoring with pulse
oximetry is questionable in relation to improved reliable outcomes,
effectiveness and efficiency.
The authors, however, went on to explain that, Due to the variety of outcome
variables used in the four studies, there are no two groups which could be
compared directly by formal meta-analysis.
Thus, the conclusions of this review were not based on a synthesis of a
substantial body of comparable data but rather on the only large randomized
controlled trial in which pulse oximetry has been evaluated, with some reference
to three much smaller studies. This trial, conducted by Moller et al. (34), involved
20 802 patients and is impressive in concept, the detail of the data collected and
the care with which the findings were presented. The study, however, lacked
power to show differences in mortality associated with anaesthesia between
groups. Given the observed rate of one death partially associated with
anaesthesia per 335 patients, 1.9 million patients would have been needed to
show a significant difference in outcome. Even for myocardial infarction, 500 000
patients would have been needed to show a difference in events, on the basis of
the observed rate of 1 in 650 patients. Thus, the negative findings of the Moller
studyrevealing no change in overall rates of respiratory, cardiovascular or
neurological complicationswere related to outcomes that would have required
much larger numbers of participants to be detected. It did, however, demonstrate
a 19-fold increase in the detection of hypoxaemia in the group monitored by
oximetry (p = 0.00001) as well as a significant increase in the detection of
endobronchial intubation and hypoventilation. In addition, myocardial ischaemia
occurred in half as many patients when oximetry was used.
The theoretical value of pulse oximetry lies in its ability to provide earlier,
clearer warning of hypoxaemia than that provided by clinical signs alone. This
may well reduce mortality rates and catastrophic hypoxic events, but these
proved too infrequent to be evaluated in a study of only 20 000 patients. While
anaesthesiologists still disagree about the implications of the Moller et al. study,
it confirmed unequivocally that pulse oximetry facilitates early detection of
hypoxaemia. Analysis of the data strongly suggested that oximetry improves
outcomes as well. In addition, all the other identified studies demonstrated at
least some benefit of the use of oximetry (Table II.2.1).
The results of trials of capnography are less clear, partly because its value is
too obvious to require a randomized trial. Oesophageal intubation and
hypoventilation are potentially disastrous if not identified early, and they can be
detected reliably and promptly by the use of capnography (9,42). This is not the
case with clinical signs alone. Capnography can also facilitate the detection of
endobronchial intubation and airway circuit disconnections (43). No reasonable
ethics board is likely to permit a randomized trial of capnography.
32
Table II.2.1 Other studies of pulse oximetry and its demonstrated benefits
Study
Benefit
Incident reporting: In the seminal work of Cooper and his group (44), reporting of
incidents identified failure to deliver oxygen to patients as the leading cause of
mortality during anaesthesia. Over a decade ago, qualitative analysis of 2000
incidents showed a reduction in cardiac arrest when pulse oximetry was used
(45), 9% of which were first detected by pulse oximetery. A theoretical analysis of
the subset of 1256 incidents involving general anaesthesia showed that pulse
oximetry on its own would have detected 82% of them. Of these, 60% would have
been detected before any potential for organ damage occurred. Capnography
alone would have detected 55% of these 1256 incidents. If both oximetry and
33
capnography had been used in combination, 88% of the adverse events would
have been detected, 65% before potential permanent damage (46). A recent
review of 4000 incidents and over 1200 medico-legal notifications reported by
anaesthetists in Australia and New Zealand revealed no cases of hypoxic brain
damage or death due to inadequate ventilation or misplaced tubes since the
introduction of oximetry and capnography (10).
oximetry and capnography over time in the Closed Claim Project 2 of the
American Society of Anesthesiologists showed that although the number of
damaging events due to respiratory failure decreased, the number of
cardiovascular damaging effects increased (47). A separate analysis based on
changes in the patterns of incident reporting indicated, however, that
catastrophic hypoxic events are much less common today than they were before
the introduction of these monitors (10). Anaesthesia is safer today than it was
before these techniques were introduced, particularly in the developed world,
where oximetry and capnography are used with nearly 100% compliance.
34
patient of use of pulse oximetry, but the cost of probes over time is likely to equal
or exceed that of the actual device. Reliable, resistant probes are needed. The cost
of capnography is somewhat higher, and maintenance is a little more challenging
than for oximetry.
35
Figure 2.1 Proposed list of anaesthesia safety checks before any anaesthetic
Patient name ________________ Number _______________ Date of birth ___/___/___
Procedure_________________________________________
Check resources
Airway
(Mallampati classification)
Aspiration risk?
No
Allergies?
No
Abnormal investigations?
Medications?
co-Morbidities?
Site_________________
No
No
No
Present
and
functioning
Airway
Masks
Airways
Laryngoscopes (working)
Tubes
Bougies
Breathing
Leaks (a fresh gas flow of 300 ml/min
maintains a pressure of >30 cm H2O)
Soda lime (colour, if present)
Circle system (two-bag test, if present)
suCtion
Emergency
Assistant
Adrenaline
Suxamethonium
Self-inflating bag
Tilting table
36
Facilities: The operating room should be of an appropriate size, well lit, conform
to relevant electrical safety codes and meet design requirements that minimize
hazards from fire, explosion and electrocution. Electricity and fresh water should
always be supplied, and a back-up electrical generator should be immediately
available. A maintenance programme must be established in each hospital. All
anaesthetic and ancillary equipment should be inspected regularly by qualified
personnel and a maintenance record kept. Ideally, routine maintenance should
not interrupt clinical services.
Secure storage is required for medications, particularly opioid drugs, and
anaesthetic equipment. A refrigerator is required for storing drugs such as
suxamethonium. Infection control measures are required to ensure that
potentially infectious materials or agents are not transferred between patients or
personnel. These should include respiratory equipment (e.g. disposable filters to
protect patients and circuits), syringes, infusion pump administration sets and
multi-dose drug vials. Sterile practice must be followed for clinical procedures
such as spinal anaesthesia or insertion of central venous lines.
Wherever obstetric anaesthesia is performed, a separate area for assessment
and resuscitation of newborns, including designated oxygen, suction apparatus,
electrical outlets, a source of radiant heat and equipment for neonatal airway
management and resuscitation, should be provided.
Policies about the running of operating rooms should be agreed. These should
include details on the composition and organization of operating schedules. A
record-keeping system (paper or electronic) for anaesthesia and surgery is
essential.
part of the system but cannot function safely on its own. A professionally trained
anaesthesia provider and patient monitoring devices are also mandatory for the
delivery of safe care. Anaesthesia equipment should be suitable for the full range
of patients treated at the facility. In addition, it should function effectively in the
local environment.
Anaesthesia can be given intravenously, using agents such as ketamine, or as
inhaled mixtures of volatile gases, such as halothane or isoflurane. Anaesthesia
gases can be delivered through continuous flow equipment (e.g. a Boyles
machine), which depends on supplies of compressed gases, or by drawover
equipment (e.g. an Epstein Macintosh Oxford [EMO] system), which uses
ambient air with added oxygen. In both systems, a vaporizer is needed to deliver
an accurate concentration of the volatile agent.
In hospitals with unreliable compressed gas supplies, continuous-flow
anaesthesia machines cannot function safely; in this situation, drawover
equipment or machines based on oxygen concentrators have considerable
advantages. When anaesthesia machines are purchased, the local environment
must be taken into account to ensure that the machine will function correctly and
can be maintained or repaired.
Gas supplies in anaesthesia: Oxygen is essential for almost all anaesthesia and
37
supplied to operating rooms in cylinders or via pipelines from a central oxygen
distribution point. Hospital oxygen systems may be based on liquid oxygen
plants, large cylinders in central banks or oxygen concentrators. Whichever
system is used, there must be a method for confirming that the oxygen supplies
are adequate before starting anaesthesia. There should always be a back-up
source of oxygen, such as a reserve cylinder. Medical gas pipeline systems,
connectors, pressure regulators and terminal units should meet national
standards for identification, construction and installation. All safety regulations
for the preparation, storage, identification and use of medical gases, anaesthetic
drugs and related materials must be met. Wherever anaesthetic gases are used,
scavenging systems within the airway circuit should be in place to reduce the
risk for long-term exposure.
When oxygen concentrators are installed, users must be aware that the
fraction of inspired oxygen (FiO2) delivered can vary between 0.93 and 0.99.
Concentrators differ in size: some are capable of supplying an entire hospital,
while others are designed to be used as the oxygen source for a single machine.
Air is commonly used during anaesthesia. Medical air is normally supplied by
pipeline from a central compressed supply and is often used for a number of other
purposes in operating rooms (e.g. for power tools and tourniquets) in addition to
anaesthesia. Ambient air is used in drawover anaesthesia.
Nitrous oxide is an analgesic gas often used in anaesthesia. It is supplied as a
liquid in high-pressure cylinders and vaporizes to form the gas breathed during
anaesthesia. Nitrous oxide is always used with oxygen. Anaesthesia machines
should be designed so that it is impossible to administer a hypoxic mixture of
nitrous oxide. In many countries, nitrous oxide is expensive. It is not often used
in modern anaesthesia and is not classified as an essential gas. In situations of
limited resources, it is safer to dispose with nitrous oxide altogether.
38
hypoxic during surgery. A redundant system such as this is essential, as the
consequence of hypoxia can be catastrophic. Hypoxia is highly preventable with
careful planning and monitoring. Adequate illumination and exposure of the
patient can also provide visual clues to hypoxia by allowing observation of the
lips or nail beds.
As the adequacy of the airway, breathing and circulation is essential for safe
delivery of anaesthesia, continuous monitoring is extremely important. For the
first two, this can be accomplished by observation and auscultation at the very
least, or by using a precordial, pretracheal or oesophageal stethoscope. When a
breathing circuit is used, the reservoir bag can also be observed. The correct
placement of an endotracheal tube can be confirmed, as can the adequacy of
ventilation, by displaying the expired carbon dioxide waveform and concentration
by capnography. When mechanical ventilation is used, disconnect alarms are
essential to prevent catastrophic disconnection of the patient from the ventilator.
Circulation is easily monitored by palpation, auscultation, a display of the pulse
waveform or electrocardiograph trace. Pulse oximetry has the added benefit of
continuous monitoring of both tissue perfusion and heart rate. Arterial blood
pressure provides a measure of the adequacy of the peripheral circulation. It can
be measured simply with a blood pressure cuff at appropriate intervals (usually
at least every 5 minutes, and more frequently if indicated by clinical
circumstances). Continuous measurement and display of arterial pressure using
invasive monitoring may also be necessary in certain circumstances.
Homeostatic mechanisms for maintaining body temperature are frequently
undermined during anaesthesia. Hypothermia can increase the risk for infection
and cause problems of hypocoagulation. Hyperthermia can be one of the first
signs of a medication or anaesthetic reaction. A means of measuring body
temperature is an important component of patient monitoring and should be
used at frequent intervals where clinically indicated, such as in a prolonged
operation or in young children.
Finally, the depth of anaesthesia must be assessed regularly throughout the
operation to ensure appropriate levels of pain control and sedation. This includes
an assessment of the state of paralysis when neuromuscular blocking agents are
used.
39
Table II.2.2 Guide to infrastructure, supplies and anaesthesia standards at
three levels of health-care facilities
Level 1 - Small hospital or health
centre
(Should meet at least highly
recommended anaesthesia
standards)
Essential procedures
Essential procedures
Essential procedures
Normal delivery
Uterine evacuation
Circumcision
Hydrocoele reduction, incision and
drainage
Wound suturing
Control of haemorrhage with pressure
dressings
Debridement and dressing of wounds
Temporary reduction of fractures
Cleaning or stabilization of open and
closed fractures
Chest drainage (possibly)
Abscess drainage
Personnel
Personnel
Personnel
Drugs
Drugs
Drugs
40
Morphine 10 mg/ml, 1 ml
Epinephrine (adrenaline) 1 mg
Atropine 0.6 mg/ml
Appropriate inhalation anaesthetic if
vaporizer available
Equipment: disposable
Equipment: disposable
Equipment: disposable
Examination gloves
Intravenous infusion and drug injection
equipment
Suction catheters size 16 FG
Airway support equipment, including
airways and tracheal tubes
Oral and nasal airways
Electrocardiograph electrodes
Intravenous equipment (minimum fluids:
normal saline, Ringer lactate and dextrose
5%)
Paediatric giving sets
Suction catheters size 16 FG
Sterile gloves sizes 68
Nasogastric tubes sizes 1016 FG
Oral airways sizes 0004
Tracheal tubes sizes 38.5 mm
Spinal needles sizes 22 G and 25G
Batteries size C
* It is preferable to combine these monitoring modalities in one unit.
Adapted in part from (28,49)
41
Recommendations
Highly recommended:
42
Recommended:
References
1. Arbous MS, et al. Impact of anesthesia management characteristics on severe
morbidity and mortality. Anesthesiology, 2005, 102:25768.
2. Buck N, Devlin HB, Lunn JN, eds. The report of the confidential enquiry into
perioperative deaths 1987. Oxford, The Nuffield Provincial Hospitals Trust, King's
Fund, 1987.
3. Lienhart A, et al. [Preliminary results from the SFARINSERM inquiry on
anaesthesia-related deaths in France: mortality rates have fallen ten-fold over the
past two decades.] Bulletin de l'Academie Nationale de Medecine, 2004, 188:142941.
4. Mackay P, Cousins M. Safety in anaesthesia. Anaesthesia and Intensive Care, 2006,
34:3034.
5. MacKay P. Safety of anesthesia in Australia. A review of anaesthesia mortality 1997
1999. Melbourne, Australian and New Zealand College of Anaesthetists, 2002.
6. Gibbs N. Safety of anesthesia in Australia. A review of anaesthesia mortality 2000
2002. Melbourne: Australian and New Zealand College of Anaesthetists, 2006.
7. Lagasse RS. Anesthesia safety: model or myth? A review of the published literature
and analysis of current original data. Anesthesiology, 2002, 97:160917.
8. Cooper JB, Gaba D. No myth: anesthesia is a model for addressing patient safety.
Anesthesiology, 2002, 97:13357.
43
9. Eichhorn JH. Prevention of intraoperative anesthesia accidents and related severe
injury through safety monitoring. Anesthesiology, 1989, 70:5727.
10. Runciman WB. Iatrogenic harm and anaesthesia in Australia. Anaesthesia and
Intensive Care, 2005, 33:297300.
11. McKenzie AG. Mortality associated with anaesthesia at Zimbabwean teaching
hospitals. South African Medical Journal, 1996, 86:33842.
12. Heywood AJ, Wilson IH, Sinclair JR. Perioperative mortality in Zambia. Annals of
the Royal College of Surgeons of England, 1989, 71:3548.
13. Hansen D, Gausi SC, Merikebu M. Anaesthesia in Malawi: complications and deaths.
Tropical Doctor, 2000, 30:1469.
14. Ouro-Bang'na Maman AF, et al. Deaths associated with anaesthesia in Togo, West
Africa. Tropical Doctor, 2005, 35:2202.
15. Hawkins JL, et al. Anesthesia-related deaths during obstetric delivery in the United
States, 1979-1990. Anesthesiology 1997, 86:277-84.
16. Cooper GM, McClure JH. Maternal deaths from anaesthesia. An extract from Why
Mothers Die 20002002, the Confidential Enquiries into Maternal Deaths in the
United Kingdom; Chapter 9: Anaesthesia. British Journal of Anaesthesia, 2005,
94:41723.
17. Weindling AM. The confidential enquiry into maternal and child health (CEMACH).
Archives of Disease in Childhood, 2003, 88:10341037.
18. Enohumah KO, Imarengiaye CO. Factors associated with anaesthesia-related
maternal mortality in a tertiary hospital in Nigeria. Acta Anaesthesiologica
Scandinavica, 2006, 50:20610.
19. Fenton PM, Whitty CJM, Reynolds F. Caesarean section in Malawi: prospective study
of early maternal and perinatal mortality. British Medical Journal, 2003, 327:587.
20. Hodges SC, et al. Anaesthesia services in developing countries: defining the problems.
Anaesthesia, 2007, 62:411.
21. Binam F, et al. [Anaesthesia practices in Yaounde (Cameroon)]. Annales Francaises
d'Anesthesie et de Reanimation, 1999, 18:64756.
22. Kimaro E, Towey RM. Anaesthesia in rural Tanzania. Tropical Doctor, 2001, 31:102
4.
23. Towey R, Kimaro E. Only if she has a fishing rod! British Medical Journal, 1998,
317:1711.
24. Mavalankar DV, Rosenfield A. Maternal mortality in resource-poor settings: policy
barriers to care. American Journal of Public Health, 2005, 95:2003.
25. Millar S. Obstetric care in Georgia and Armenia. Anaesthesia News, 2007, 235:35.
26. Eichhorn JH, et al. Standards for patient monitoring during anesthesia at Harvard
Medical School. Journal of the American Medical Association, 1986, 256:101720.
27. Eichhorn
JH.
The
standards
formulation
process.
European
Journal
of
28. International Task Force on Anaesthesia Safety. International standards for a safe
practice of anaesthesia. European Journal of Anaesthesiology, 1993, 10 Suppl. 7:12
5.
29. World Federation of Societies of Anaesthesiology. 2008 International standard for
safe practice of anaesthesia. http://www.anaesthesiologists.org (accessed 10 May
2008).
44
30. Pedersen T, Dyrlund Pedersen B, Moller AM. Pulse oximetry for perioperative
monitoring. Cochrane Database of Systematic Reviews, 2003(2): CD002013.
31. McGlynn E, et al. The quality of health care delivered to adults in the United States.
New England Journal of Medicine, 2003, 348:263545.
32. Eichhorn JH. Pulse oximetry as a standard of practice in anesthesia. Anesthesiology,
1993, 78:4236.
33. Thoms GM, McHugh GA, O'Sullivan E. The Global Oximetry initiative. Anaesthesia,
2007, 62 Suppl 1:757.
34. Moller JT, et al. Randomized evaluation of pulse oximetry in 20,802 patients: II.
Perioperative events and postoperative complications. Anesthesiology, 1993, 78:445
53.
35. Bierman MI, Stein KL, Snyder JV. Pulse oximetry in the postoperative care of cardiac
surgical patients. A randomized controlled trail (comment). Chest, 1992, 102:1367
70.
36. Moller JT, et al. Hypoxaemia is reduced by pulse oximetry monitoring in the
operating theatre and in the recovery room. British Journal of Anaesthesia, 1992,
68:14650.
37. Moller JT, et al. Perioperative monitoring with pulse oximetry and late postoperative
cognitive dysfunction. British Journal of Anaesthesia, 1993, 71:3407.
38. Cote CJ, et al. A single-blind study of pulse oximetry in children. Anesthesiology,
1988, 68:1848.
39. Cote CJ, et al. A single-blind study of combined pulse oximetry and capnography in
children. Anesthesiology, 1991, 74:9807.
40. Cullen DJ, et al. Effect of pulse oximetry, age, and ASA physical status on the
frequency of patients admitted unexpectedly to a postoperative intensive care unit
and the severity of their anesthesia-related complications. Anesthesia and Analgesia,
1992, 74:1818.
41. Mateer JR, et al. Continuous pulse oximetry during emergency endotracheal
intubation. Annals of Emergency Medicine, 1993, 22:6759.
42. Holland R, Webb RK, Runciman WB. The Australian Incident Monitoring Study.
Oesophageal intubation: an analysis of 2000 incident reports. Anaesthesia and
Intensive Care, 1993, 21:60810.
43. Russell WJ, et al. The Australian Incident Monitoring Study. Problems with
ventilation: an analysis of 2000 incident reports. Anaesthesia and Intensive Care,
1993, 21:61720.
44. Cooper JB, Newbower RS, Kitz RJ. An analysis of major errors and equipment
failures in anesthesia management: considerations for prevention and detection.
Anesthesiology, 1984, 60:3442.
45. Runciman WB, et al. The pulse oximeter: applications and limitationsan analysis of
2000 incident reports. Anaesthesia and Intensive Care, 1993, 21:54350.
46. Webb RK, et al. The Australian Incident Monitoring Study. Which monitor? An
analysis of 2000 incident reports. Anaesthesia and Intensive Care, 1993, 21:52942.
47. Cheney FW, et al. Trends in anesthesia-related death and brain damage: a closed
claims analysis. Anesthesiology, 2006, 105:10816.
48. Stoneham M, Saville G, Wilson IH. Knowledge about pulse oximetry among medical
and nursing staff. Lancet, 1994, 344:133942.
49. World Health Organization. Surgical care at the district hospital. Geneva, World
Health Organization, 2003.
45
Objective 3: The team will recognize and effectively prepare for life-threatening
loss of airway or respiratory function.
Securing the airway of a patient undergoing general anaesthesia is the single
most critical event during induction. Reduced tone in the upper airway results in
airway collapse and diminished protective reflexes expose the patient to the risk
of aspiration. In addition, most anaesthetics reduce respiratory drive, and
administration of muscle relaxants at clinical doses causes complete paralysis,
preventing patients from breathing on their own. In this situation, the
anaesthetized patient is extremely vulnerable to hypoxia and completely
dependent on the anaesthesia professional for airway maintenance and
ventilation. In the past, adverse outcomes associated with respiratory events
were the largest class of injury in the American Society of Anesthesiologists
Closed Claims Project (1). Inadequate ventilation, oesophageal intubation,
difficult tracheal intubation and aspiration were the most common mechanisms
of respiratory-related adverse outcomes (24). Inability to maintain oxygenation
in a patient is one of the most feared situations in anaesthesia. Inadequate
management of a failed airway, including inadequate identification of its risk,
continues to contribute to preventable mortality associated with anaesthesia
around the world.
Incidence of difficult and failed airway management
A failed airway has been defined as three unsuccessful attempts at
orotracheal intubation by a skilled practitioner or failure to maintain acceptable
oxygen saturation (usually 90%) in an otherwise normal patient (5). While
failure to secure an airway is infrequent in much of the developed world, it can
have catastrophic consequences for the patient. Mortality from anaesthesiarelated procedures frequently can be due to failure to recognize and address
airway and ventilation problems that compromise the patients oxygenation.
While many strategies can be used to manage a difficult airwaysuch as mask
ventilation, insertion of a laryngeal mask airway, endotracheal intubation, fibreoptic intubation and, in the most extreme cases, creation of a surgical airway
simultaneous failure of these approaches is fatal.
Difficulties can arise with any of the strategies described above, and while the
incidence of these difficulties has been estimated, it varies with the skill of the
anaesthetist and the case mix. Table II.3.1 presents the reported incidence rates
of failure with various techniques for airway management. Apart from failure of
these techniques, some situations are particularly risky and can result in airway
loss. Airway difficulties during emergency intubation can occur in up to 20% of
emergency cases, and the incidence of failed intubation and ventilation is 10-fold
higher in obstetric anaesthesia than in other settings (6,7).
A number of reviews show that airway loss continues to plague anaesthesia
delivery. The ninth report of the Victorian Consultative Council on Anaesthetic
Mortality and Morbidity in Australia listed 41 anaesthesia-related events
between 2000 and 2002, giving an estimated mortality rate associated with
anaesthesia of 1 in 47 000 (11). Airway difficulties were the cause of two deaths
and 11 morbid events; aspiration was the cause of a further five deaths and two
major morbid events; and 12 cases of acute negative pressure pulmonary oedema
were attributed to airway obstruction during emergence from anaesthesia. In
addition, failures in airway management or ventilation contributed to 16 deaths
reported throughout Australia over the same period (12). The Australian Incident
46
Monitoring Study (AIMS) reported 160 difficult intubations; lack of an adequate
preoperative assessment and preparation contributed to the failure to predict
difficulties in over half of these cases (13). Difficulty with face-mask ventilation
occurred in 23 incidents, and 12 patients required emergency airway procedures.
While deaths were rare, the report concluded that problems with airway
management remain a challenge.
0.16
2-6
Intubation (10)
0.050.35
0.00010.02
Similar problems are reported from other developed countries. In the United
States, 179 claims arising from difficulties in airway management were identified
in the American Society of Anesthesiologists Closed Claims Project database
between 1985 and 1999 (14). Most (87%) occurred during perioperative care,
while the remainder occurred at locations other than the operating room. Death
resulted from these airway crises 58% of the time and brain damage 100% of the
time, and persistent attempts at intubation were associated with an increased
likelihood of death or brain damage. A study of mortality associated with
anaesthesia in the Netherlands showed a mortality rate of 1.4 per 10 000
anaesthesias; of the 119 anaesthesia-related deaths, 12 (10%) were associated
with ventilatory management (15).
Much higher avoidable mortality associated with anaesthesia has been
reported in developing countries. In Zimbabwe, a rate of 1:3000 was reported,
with airway catastrophe being a major cause of death (16). In Zambia, the death
rate attributable to anaesthesia was 1:1900, half of which was a direct result of
failed airway management (17). In Malawi, the anaesthesia-attributable death
rate was 1:500, nearly all of which stemmed from failure to secure the airways or
prevent aspiration (18). In Togo, the mortality rate associated with anaesthesia
was 1:150, and eight of the 11 deaths (out of 1464 anaesthesias) were due to
compromised airways (19). These studies illustrate the hazards that surgical
patients face due to the pervasive absence of safe anaesthetic practice.
Taken collectively, these results show that failure to maintain an airway and
to ventilate and oxygenate patients adequately continues to pose a serious risk
during anaesthesia throughout the world. While there are few data from
countries with limited resources, the risk for harm is even greater when optimal
assistance, expertise and equipment are not available.
47
Airways assessment
Preoperative recognition of a difficult airway allows for appropriate
preparation and planning (2023). Failure to evaluate the airway and anticipate
problems is widely accepted as the most important factor in ventilation and
oxygenation failure (1). Therefore, every patients airway should be thoroughly
assessed before anaesthesia and the results of the assessment recorded.
A complete airway assessment includes the patients history, medical
conditions (including components of airway compromise, such as sleep apnoea
and asthma), prior surgery and anaesthesia and previous difficulties with
anaesthesia. It also includes a thorough physical examination, with particular
attention to body habitus and obesity, characteristics of the neck including
shortness or lack of mobility, and characteristics of the jaw including a receding
jaw or limited ability to open the mouth. Dentition is also an important
component of assessment: loose or protruding teeth and dentures or implants
should be noted. Several tests or investigations can be used in evaluating a
questionably difficult airway, including airway tests (discussed below) and
radiographs (including computed tomography if tracheal compression is
suspected).
A number of bedside screening tests have been proposed for identifying
difficult airways, but no single test or combination of tests can always predict a
difficult airway (8,24). As difficult intubation is rare, even highly specific and
sensitive tests have low positive predictive value (25,26). Diagnostic reliability is
increased by combining tests and using clinical judgement in evaluating
characteristics that might predispose the patient to difficulty, such as obesity or
a short, immobile neck (24). The most useful bedside test for predicting a difficult
intubation in an apparently normal patient is a combination of the Mallampati
classification and thyromental distance.
48
These screening tests are designed to help clinicians predict the potential
difficulty of intubation during airway control and management. They are
therefore useful for assessment and their use can prevent problems (32). They
cannot be used to predict potential difficulty with perfect accuracy, however, and
it would be dangerous to assume that an evaluation indicating an easy
intubation will necessarily always be a simple intubation. A patient whose
airway defies accurate prediction has the highest likelihood of catastrophe during
induction.
49
Supraglottic airway ventilation: The laryngeal mask airway has become the
device of choice for supraglottic airway ventilation. Its growing popularity, where
it is available, is testament to its superiority to manual face-mask ventilation.
Again, skill and practice are required to appropriately insert it and safely
maintain it in position, and inadequate supraglottic airway ventilation occurs
after 26% of insertions (9). Appropriate patient selection is also essential to
avoid problems and complications (40,41). Factors associated with difficult
supraglottic airway use include restricted mouth opening, upper airway
obstruction at or below the level of the larynx, a disrupted or distorted airway,
stiff lungs and a stiff cervical spine (42).
50
unsafe practice to expect safe management of difficult airways from relatively
untrained personnel with inadequate resources.
51
Face masks #3, 4 and 5 suitable for artificial ventilation
Oropharyngeal airways #3, 4, 5 and 6
Nasopharyngeal airways #6, 7 and 8
Laryngeal masks #3, 4 and 5
Endotracheal tubes, cuffed, #6, 7, and 8
Laryngoscope handles x 2
Compatible blades #3 and 4
Angled blade (e.g. Kessel blade)
Tracheal tube introducer able to hold its shape or with a coud tip
Malleable stylet
Water-soluble lubricant
Magill introducing forceps
Difficult airway algorithm flowchart
Readily available difficult airway container (should ideally be sealed, available within
60 seconds, all equipment within it compatible, restocked promptly after each use and
all staff oriented to its location)
Short laryngoscope handle
At least one alternative blade (straight)
Intubating laryngeal mask airway #3, 4 and 5, with fast-track dedicated tubes and
stabilizing rod or C-track
Specialized tracheal tubes: reinforced #5 and 6, cuffed; microlaryngoscope 5- and 6mm
Aintree intubating catheter
Flexible intubating bronchoscope with portable battery light source
Fibre-optic equipment with spare battery or light source, intubating airways, local
anaesthetic (sprays, jelly, atomisers), bite block
Easy-tube: small and adult, or Combi-tube
Airway exchange catheter
Supreme laryngeal mask airway (or equivalent) # 3, 4 and 5
Surgical cricothyroidotomy kit (scalpel with #20 blade, tracheal hook, Trousseau
dilator, 6- or 7-mm tracheal and tracheostomy tubes)
Cricothyroidotomy cannula with high-pressure jet ventilation system oxygen flow
modulator
Large-bore cricothyroidotomy cannula
Oesophageal intubation detector device such as a capnograph
Pulse oximeter
52
It is widely accepted that application of cricoid pressure is important for
preventing passive regurgitation of stomach contents, predicated on the
assumption that cricoid pressure will be applied correctly (59). In fact, the
efficacy of cricoid pressure is largely unproven, and most clinicians and their
assistants do not apply it correctly (60,61). Aggressive cricoid pressure can cause
tracheal compression and prevent ventilation or require high bag pressures; it
can also distort the airways during intubation and can create a worse view at
laryngoscopy (62,63). Thus, unskilled application of cricoid pressure might
actually increase the risks for failed intubation and regurgitation (60).
Aspiration of gastric contents may produce harm either by blockage of the
airway with solid material resulting in immediate hypoxia or by gastric acid
causing a pneumonitis. Pneumonitis, which may progress to acute respiratory
distress syndrome, is worsened by low pH of the aspirate. An appropriate period
of fasting are recommended prior to elective surgery to minimize gastric contents
and the likelihood of aspiration; this is not usually feasible in emergency surgery,
however. Patients at risk of aspiration can be treated prior to elective surgery by
either a proton pump inhibitor (e.g. omeprazole, lansoprazole) or an H2
antagonist (e.g. ranitidine, cimetidine) and prior to emergency surgery with oral
sodium citrate.
Airway disasters, while uncommon, are lethal and entirely preventable with
appropriate planning, adequate pre-induction airway evaluation and careful
preparation of the patient and equipment. The skill, experience and judgement of
a practised anaesthesia professional and the timely and appropriate support of
assistants can avert airway catastrophes and prevent death from anaesthetic
administration. All anaesthetists should have a strategy for intubation of the
difficult airway.
Recommendations
Highly recommended:
53
Recommended:
References
1. Cheney FW, Posner KL, Caplan RA. Adverse respiratory events infrequently leading
to malpractice suits. A closed claims analysis. Anesthesiology, 1991;75:9329.
2. Nimmo WS. Aspiration of gastric contents. British Journal of Hospital Medicine,
1985;34:1769.
3. Kluger MT, Short TG. Aspiration during anaesthesia: a review of 133 cases from the
Australian Anaesthetic Incident Monitoring Study (AIMS). Anaesthesia, 1999;54:19
26.
4. American Society of Anesthesiologists Task Force on Preoperative Fasting. Practice
guideline for preoperative fasting and the use of pharmacologic agents to reduce the
risk of pulmonary aspiration: application to healthy patients undergoing elective
procedures. Anesthesiology, 1999;90:896905.
5. Murphy M, Doyle DJ. Airway evaluation. In: Hung O, Murphy M, eds. Management
of the difficult and failed airway. New York, McGraw Hill; 2008:315.
6. Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia,
1984;39:110511.
7. Bair AE, et al. The failed intubation attempt in the emergency department: analysis
of prevalence, rescue techniques, and personnel. Journal of Emergency Medicine,
2002;23:13140.
8. Kheterpal S, et al. Incidence and predictors of difficult and impossible mask
ventilation. Anesthesiology, 2006;105:88591.
9. Brain AI. Laryngeal mask airway. Anesthesiology, 1992;76:1061.
10. Klock P, Benumof J. Definition and incidence of the difficult airway. In: Hagberg C,
ed. Airway management. Philadelphia, Mosby, 2007:21521.
11. McNicol L. Ninth report of the Victorian Consultative Council on Anaesthetic
Mortality and Morbidity. Melbourne, Consultative Council on Anaesthetic Mortality
and Morbidity, 2007.
12. Gibbs N, Borton C. A review of anaesthesia related mortality 2000 to 2002.
Melbourne, Australian and New Zealand College of Anaesthetists, 2006.
13. Paix AD, Williamson JA, Runciman WB. Crisis management during anaesthesia:
difficult intubation. Quality and Safety in Health Care, 2005;14:e5.
54
14. Peterson G, et al. Management of the difficult airway: a closed claims analysis.
Anesthesiology, 2005;103:339.
15. Arbous MS, et al. Mortality associated with anaesthesia: a qualitative analysis to
identify risk factors. Anaesthesia, 2001;56:114153.
16. McKenzie AG. Mortality associated with anaesthesia at Zimbabwean teaching
hospitals. South African Medical Journal, 1996;86:33842.
17. Heywood AJ, Wilson IH, Sinclair JR. Perioperative mortality in Zambia. Annals of
the Royal College of Surgeons of England, 1989;71:3548.
18. Hansen D, Gausi SC, Merikebu M. Anaesthesia in Malawi: complications and deaths.
Tropical Doctor, 2000;30:1469.
19. Ouro-Bang'na Maman AF, et al. Deaths associated with anaesthesia in Togo, West
Africa. Tropical Doctor, 2005;35:2202.
20. Benumof JL. Laryngeal mask airway and the ASA difficult airway algorithm.
Anesthesiology, 1996;84:68699.
21. Benumof JL. Management of the difficult adult airway. With special emphasis on
awake tracheal intubation. Anesthesiology, 1991;75:1087110.
22. Practice guidelines for management of the difficult airway. An updated report by the
American Society of Anesthesiologists Task Force on Management of the Difficult
Airway. Anesthesiology, 2003;98:126977.
23. Practice guidelines for management of the difficult airway. A report by the American
Society of Anesthesiologists Task Force on Management of the Difficult Airway.
Anesthesiology, 1993;78:597602.
24. Shiga T, et al. Predicting difficult intubation in apparently normal patients: a metaanalysis of bedside screening test performance. Anesthesiology, 2005;103:42937.
25. Yentis SM. Predicting difficult intubationworthwhile exercise or pointless ritual?
Anaesthesia, 2002;57:1059.
26. Tse JC, Rimm EB, Hussain A. Predicting difficult endotracheal intubation in surgical
patients scheduled for general anesthesia: a prospective blind study. Anesthesia and
Analgesia, 1995;81:2548.
27. Patil V, Zauder H. Predicting the difficulty of intubation utilizing an intubation
gauge. Anesthesiology Review, 1983;10:323.
28. Benumof J. Both a large and small thyromental distance can predict difficult
intubation. Anesthesia and Analgesia, 2003;97:1543.
29. Mallampati S. Clinical sign to predict difficult tracheal intubation (hypothesis).
Canadian Anaesthetists Society Journal, 1983;30:3167.
30. Mallampati S, et al. A clinical sign to predict difficult tracheal intubation: a
prospective study. Canadian Anaesthetists Society Journal, 1985;32:42934.
31. Samsoon G, Young J. Difficult tracheal intubation: a retrospective study.
Anaesthesia, 1987;42:48790.
32. Kluger MT, et al. Inadequate pre-operative evaluation and preparation: a review of
197 reports from the Australian incident monitoring study. Anaesthesia,
2000;55:11738.
33. Crosby ET, et al. The unanticipated difficult airway with recommendations for
management. Canadian Journal of Anaesthesia, 1998;45:75776.
34. Petrini F, et al. Recommendations for airway control and difficult airway
management. Minerva Anestesiologica, 2005;71:61757.
55
35. Frova G. [The difficult intubation and the problem of monitoring the adult airway.
Italian Society of Anesthesia, Resuscitation, and Intensive Therapy (SIAARTI)].
Minerva Anestesiologica, 1998;64:36171.
36. Frova G, et al. Recommendations for airway control and difficult airway management
in paediatric patients. Minerva Anestesiologica, 2006;72:72348.
37. Henderson JJ, et al. Difficult Airway Society guidelines for management of the
unanticipated difficult intubation. Anaesthesia, 2004;59:67594.
38. Boisson-Bertrand D, et al. [Difficult intubation. French Society of Anesthesia and
Intensive Care. A collective expertise]. Annales francaises d'anesthesie et de
reanimation, 1996;15:20714.
39. Langeron O, et al. Prediction of difficult mask ventilation. Anesthesiology,
2000;92:122936.
40. Brain AI. The development of the laryngeal maska brief history of the invention,
early clinical studies and experimental work from which the laryngeal mask evolved.
European Journal of Anaesthesiology, 1991;Suppl 4:517.
41. Ferson DZ, Brain AI. Laryngeal mask airway. In: Hagberg C, ed. Airway
management, 2nd ed. Philadelphia, Mosby, 2007:476501.
42. Hung O, Murphy M. Changing practice in airway management: are we there yet?
Canadian Journal of Anaesthesia, 2004;51:9638.
43. Griffith HR, Johnson GE. The use of curare in general anaesthesia. Anesthesiology,
1942;3:41820.
44. Dawson AJ, et al. Fibreoptic intubation skills among anaesthetists in New Zealand.
Anaesthesia and Intensive Care, 2005;33:77783.
45. Popat M. Practical fibreoptic intubation. Amsterdam, Elsevier, 2001.
46. Ferson DZ, et al. Use of the intubating LMA-Fastrach in 254 patients with difficultto-manage airways. Anesthesiology, 2001;95:117581.
47. Rosenblatt WH, et al. Retrograde fiberoptic intubation. Anesthesia and Analgesia,
1997;84:11424.
48. Bray JK, Yentis SM. Attitudes of patients and anaesthetists to informed consent for
specialist airway techniques. Anaesthesia, 2002;57:10125.
49. Mason RA, Fielder CP. The obstructed airway in head and neck surgery.
Anaesthesia, 1999;54:6258.
50. McClelland SH, Hardman JG. Inhalational induction of anaesthesia in adults: time
for a breath of fresh air? Anaesthesia, 2007;62:10879.
51. Yigla M, et al. Incidence of bacteraemia following fibreoptic bronchoscopy. European
Respiratory Journal, 1999;14:78991.
52. Maktabi MA, et al. Laryngeal trauma during awake fiberoptic intubation. Anesthesia
and Analgesia, 2002;95:11124.
53. Xue FS, et al. The circulatory responses to fibreoptic intubation: a comparison of oral
and nasal routes. Anaesthesia, 2006;61:63945.
54. Xue FS, et al. Blood pressure and heart rate changes during intubation: a comparison
of direct laryngoscopy and a fibreoptic method. Anaesthesia, 2006;61:4448.
55. Ovassapian A. Fiberoptic tracheal intubation in adults. In: Ovassapian A, ed.
Fiberoptic endoscopy and the difficult airway, 2nd ed. Philadelphia, LippincottRaven, 1996:72103.
56. Baker P, et al. Airway management equipment in a metropolitan region: an audit.
Anaesthesia and Intensive Care, 2007, 35:5639.
56
57. Warner M, Warner M, Weber J. Clinical significance of pulmonary aspiration during
the perioperative period. Anesthesiology, 1993;78:5662.
58. Brimacombe J, Berry A. The incidence of aspiration associated with the laryngeal
mask airway: a meta-analysis of published literature. Journal of Clinical Anesthesia,
1995;7:297305.
59. Sellick B. Cricoid pressure to control regurgitation of stomach contents during
induction of anaesthesia. Lancet, 1961;ii:4046.
60. Brimacombe J, Berry A. Cricoid pressure. Canadian Journal of Anaesthesia,
1997;44:41425.
61. Landsman I. Cricoid pressure: indications and complications. Paediatric Anaesthesia,
2004;14:437.
62. Mac G, Ball D. The effect of cricoid pressure on the cricoid cartilage and vocal cords:
an endoscopic study in anaesthetised patients. Anaesthesia, 2000;55:2638.
63. Levitan R, et al. Laryngeal view during laryngoscopy: a randomized trial comparing
cricoid pressure, backward-upward-rightward pressure, and bimanual laryngoscopy.
Annals of Emergency Medicine, 2006;47:54855.
57
Objective 4: The team will recognize and effectively prepare for risk of high blood
loss.
Loss of a large volume of blood, especially when associated with
haemodynamic instability, has been clearly associated with poor surgical
outcome (1). Controlling haemorrhage and mitigating its clinical effects by
appropriate fluid resuscitation are important components of intraoperative care.
Clinical knowledge of resuscitation in the setting of haemorrhagic hypovolaemia
was initially based on field observations of soldiers injured in battle (2). Rapid
accumulation of scientific knowledge of the physiology of shock came during the
twentieth century with controlled experiments in animal models (3). This work
conclusively demonstrated that fluid resuscitation is essential to reverse the
signs and symptoms of shock from hypovolaemia (4).
In advanced trauma care systems, standard practice dictates early initiation
of intravenous access and fluid administration to victims of trauma. In
epidemiological studies, haemorrhage has been shown to be the major cause of
death of trauma victims (5). The Advanced Trauma Life Support course directed
by the American College of Surgeons mandates the insertion of two large-bore
intravenous lines for all traumatically injured patients as soon as possible,
including before hospitalization (6). This allows the administration of fluid and
medications before arrival at the hospital and minimizes delays once the patients
have arrived at a facility capable of delivering care. Early attempts at manual
pressure control of external haemorrhage are also important.
Class II
Class III
Class IV
750 ml
7501500 ml
15002000 ml
> 2000 ml
15%
1530%
3040%
> 40%
Pulse rate
< 100
> 100
> 120
> 140
Normal
Normal to
decreased
Decreased
Markedly
decreased
Mental status
Normal to slightly
anxious
Mildly anxious
Anxious and
confused
Confused or
lethargic
Urine output
Normal
Reduced
Minimal
Nil
Crystalloid
Crystalloid
Crystalloid and
blood
Crystalloid and
blood
Blood loss
Blood pressure
Fluid replacement
From American College of Surgeons Advanced Trauma Life Support manual (6)
58
tachycardia, hypotension and anxiety. With a volume loss greater than 30%,
hypotension, sustained increases in heart rate and confusion are clearly present.
Blood loss exceeding 40% of the total body circulating volume is immediately lifethreatening and manifests as a mentally altered, hypotensive and oliguric
patient. While the changes in pulse rate listed for the different classes of shock
usually hold true, massive rapid uncompensated blood loss can paradoxically
result in relative bradycardia (7,8). In addition, the absence of tachycardia does
not reliably rule out severe blood loss (912). Other important caveats to the
characteristics of different classes of shock are that the blood pressure of young
patients (particularly children) can remain fairly high even after profound
haemorrhage and that blood pressure and heart rate can be unreliable indicators
in patients receiving beta-blockers or other medications with cardiovascular
effects. Therefore, the clinical picture of shock might not manifest exactly as
depicted in text books. Nonetheless, severe haemorrhage is an immediate threat
to life and must be managed immediately.
The aggressiveness of fluid resuscitation during prehospital management is
still the subject of much debate. Conflicting reports of increased mortality
associated with fluid resuscitation during uncontrolled and ongoing blood loss
has led some to advocate fluid restriction until definitive care begins (13,14). The
type of fluid is also the subject of discussion, and the usefulness of various types
of crystalloid solutions in prehospital management continues to be evaluated
(15). Nevertheless, there is no debate on the mandatory need for fluid support
during definitive intervention for hypovolaemic patients.
Hypovolaemia can have disastrous consequences for surgical patients and has
been recognized as a major contributor to avoidable mortality and morbidity.
Identifying current or potential hypovolaemia and instituting a resuscitation
plan are essential for reducing surgical morbidity and mortality. Preparation for
instability in a patient with hypovolaemia includes understanding the degree of
and reason for the hypovolaemia, establishing appropriate intravenous access,
ensuring adequate supplies of fluids for resuscitation, confirming the availability
of blood products where appropriate, and coordinating resuscitation with the
operating team. As blood loss is a major contributor to hypovolaemia, control of
haemorrhage must be coupled with a well-thought-out plan for resuscitation to
optimize the patients outcome. Dehydration also contributes to preoperative
hypovolaemia. It can be due to inadequate fluid intake by an ill patient, excess
fluid loss (through e.g. diarrhoea or vomiting) or redistribution of fluid volume
out of the circulation (as in e.g. bowel obstruction or peritonitis). Additionally,
vasodilation due to sepsis or spinal cord injury can result in a relative
hypovolaemic state. Accurate identification of these situations allows timely,
targeted therapy and can reduce mortality (16).
Intraoperative care differs from prehospital resuscitation in that
intraoperative manoeuvres can be both the cause and the treatment of
continuing blood loss. Therefore, adequate preoperative preparation is essential
to mitigate or avoid the physiological derangements of intraoperative
hypovolaemia caused by excessive blood loss or other physiological events, such
as decreased sympathetic tone due to anaesthetic agents or third spacing of
fluids. When loss of a large volume of blood is either expected or a major risk,
placement of adequate intravenous access before skin incision will help the team
to keep the volume status adequate.
59
Resuscitation of hypovolaemic patients
Patients who present for surgery in a volume-depleted state should be
resuscitated before surgery whenever possible. Intravenous access should be
obtained promptly and resuscitation begun in an efficient fashion to minimize
delays in performing the operation. Fluid deficits should be remedied by infusion
of crystalloid solutions. In certain circumstances, some of the fluid deficit can be
replaced by oral intake; however, this is often undesirable in gastrointestinal
conditions, impending general anaesthetic or other clinical concerns. Monitoring
of fluid status should be instituted wherever feasible, should be tailored to the
specific clinical situation and should include regular evaluation of haemodynamic
parameters, such as pulse rate and blood pressure (see Objective 2). It may also
include urinary catheterization, central venous cannulation and other invasive
monitoring. Communication among the clinicians caring for the patient in the
pre-, intra- and postoperative periods will improve resuscitation and allow for
appropriate timing of the operation.
Prevention of blood loss
Some procedures, such as caesarean section or major vascular surgery,
inevitably involve heavy blood loss. Other circumstances can also predispose a
patient to unusually heavy bleeding during an operation, such as reoperation or
dissections known to be difficult. The first step in mitigating blood loss during an
operation is prevention. Known coagulation deficits should be corrected before
surgery whenever clinically possible. The surgical, anaesthetic and nursing
personnel involved in an operation should all be aware of the potential for major
blood loss before the procedure and be prepared for it.
Ensuring appropriate intravenous access is a critical step and allows the
anaesthetist to respond to fluctuations in blood pressure (17). Access may take
the form of large-bore peripheral lines, central venous catheters or some
combination of the two. If the expected blood loss is greater than 500 ml for an
adult or 7 ml/kg in children, the observed standard of practice dictates the
insertion of two wide-bore intravenous lines or a central venous catheter (also
preferably large-bore) to allow for adequate resuscitation. When the need for a
blood transfusion is anticipated, operating teams should communicate early with
the blood bank to ensure prompt availability of cross-matched blood products.
When the patient is bleeding before surgery, it is imperative that all members of
the operating team be aware of the source and estimated volume of blood loss.
Management of blood loss
If surgery is undertaken in an emergency or urgently for haemorrhage,
complete preoperative resuscitation is often neither practical nor desirable, and
resuscitation must be coupled with surgery to stem the haemorrhage. Again,
large-bore intravenous access must be obtained and resuscitative measures
instituted as soon as possible before operation. Volume resuscitation includes
infusion of crystalloid solutions and transfusion of blood products or other volume
expanders. Evidence is accumulating for the effectiveness of transfusing freshfrozen plasma, when available, for each one or two units of packed red blood cells
to combat coagulopathy (1821). While increasing the amount of fresh-frozen
plasma used, this may decrease the overall use of blood products by decreasing
the amount of packed red blood cells required. Where appropriate and available,
60
mechanisms to collect and re-transfuse shed blood may be used. In some
situations, temporizing measures should be taken to control bleeding in order to
allow fluid resuscitation to catch up with accumulated blood loss before definitive
surgical management. In other situations, intra-abdominal packing to temporize
bleeding is prudent and may allow for correction of coagulopathy, hypothermia
and acidosis. In such damage control surgery, abdominal re-exploration follows
2472 hours after the initial surgical exploration (2224). The team of
anaesthetists, surgeons and nurses must all be aware of the plan for
resuscitation so that they can take appropriate measures to reduce the morbidity
of haemorrhage.
Hypovolaemia represents a situation in which clear, unhindered
communication is essential to optimize patient care. Coordination of care during
resuscitation and the operation combined with an anaesthetic plan based on the
patients physiological state can make a profound difference in intraoperative
management.
Recommendations
Highly recommended:
Before skin incision, the team should discuss the risk for large-volume
blood loss and, if it is significant, ensure that appropriate intravenous
access is established.
Recommended:
References
1. Gawande AA, et al. An Apgar score for surgery. Journal of the American College of
Surgeons, 2007, 204:2018.
2. Cannon WB, Fraser J, Cowell E. The preventative treatment of wound shock. Journal
of the American Medical Association, 1918, 70:61821.
3. Shires T, et al. Fluid therapy in hemorrhagic shock. Archives of Surgery, 1964,
88:68893.
4. Feliciano D, Mattox K, Moore E. Trauma. 6th ed. New York, McGraw Hill, 2008.
5. Sauaia A, et al. Epidemiology of trauma deaths: a reassessment. Journal of Trauma,
1995, 38:18593.
6. American College of Surgeons Committee on Trauma. Advanced trauma life support
for doctors. Chicago, American College of Surgeons, 1997.
7. Demetriades D, et al. Relative bradycardia in patients with traumatic hypotension.
Journal of Trauma, 1998, 45:5349.
61
8. Vargish T, Beamer KC. Delta and mu receptor agonists correlate with greater
depression of cardiac function than morphine sulfate in perfused rat hearts.
Circulatory Shock, 1989, 27:24551.
9. Little RA, Jones RO, Eltraifi AE. Cardiovascular reflex function after injury. Progress
in Clinical and Biological Research, 1988, 264:191200.
10. Little RA, et al. Components of injury (haemorrhage and tissue ischaemia) affecting
cardiovascular reflexes in man and rat. Quarterly Journal of Experimental
Physiology, 1984, 69:75362.
11. Little, RA, Stoner HB. Effect of injury on the reflex control of pulse rate in man.
Circulatory Shock, 1983, 10:16171.
12. Victorino GP, Battistella FD, Wisner DH. Does tachycardia correlate with
hypotension after trauma? Journal of the American College of Surgeons, 2003,
196:67984.
13. Bickell WH, et al. The detrimental effects of intravenous crystalloid after aortotomy
in swine. Surgery, 1991, 110:52936.
14. Bickell WH, et al. Immediate versus delayed fluid resuscitation for hypotensive
patients with penetrating torso injuries. New England Journal of Medicine, 1994,
331:11059.
15. Brasel KJ, et al. Hypertonic resuscitation: design and implementation of a
prehospital intervention trial. Journal of the American College of Surgeons, 2008,
206:22032.
16. Rivers E, et al. Early goal-directed therapy in the treatment of severe sepsis and
septic shock. New England Journal of Medicine, 2001, 345:136877.
17. Gaba DM, Fish KJ, Howard SK. Crisis management in anesthesiology. New York,
Churchill Livingston, 1994.
18. Gonzalez EA, et al. Fresh frozen plasma should be given earlier to patients requiring
massive transfusion. Journal of Trauma, 2007, 62:1129.
19. Hirshberg A, et al. Minimizing dilutional coagulopathy in exsanguinating
hemorrhage: a computer simulation. Journal of Trauma, 2003, 54:45463.
20. Ho AM, Karmakar MK, Dion PW. Are we giving enough coagulation factors during
major trauma resuscitation? American Journal of Surgery, 2005, 190:47984.
21. Spinella PC, et al. Effect of plasma and red blood cell transfusions on survival in
patients with combat related traumatic injuries. Journal of Trauma, 2008, 64(Suppl
2):S6978.
22. Rotondo MF, et al. 'Damage control': an approach for improved survival in
exsanguinating penetrating abdominal injury. Journal of Trauma, 1993, 35:37583.
23. Parker PJ. Damage control surgery and casualty evacuation: techniques for surgeons,
lessons for military medical planners. Journal of the Royal Army Medical Corps,
2006, 152:20211.
24. Burch JM, et al. Abbreviated laparotomy and planned reoperation for critically
injured patients. Annals of Surgery, 1992, 215:47684.
62
63
Objective 5: The team will avoid inducing an allergic or adverse drug reaction for
which the patient is known to be at significant risk.
A medication error can be defined as an error in prescription, dispensing or
administration of a drug (1). Medication errors are a major problem in every
health system and every country and have featured prominently in studies of
iatrogenic injury conducted in the United States and many other countries (2). In
the United States, at least 1.5 million people are injured annually, and the costs
to the health system exceed US$3.5 billion each year (3). Perioperative errors in
drug administration contribute to this problem. In the Closed Claims Project of
the American Society of Anesthesiologists, drug administration errors were found
to result in serious problems, including death in 24% and major morbidity in 34%
of the cases reviewed (4).
Human error contributes substantially to injuries due to medication errors. In
an early analysis of critical incidents in anaesthesia, Cooper et al. (5) found that
a common cause of such incidents was inadvertent substitution of one drug-filled
syringe for another. A further analysis published by Coopers team (6) identified
syringe swapping, ampoule switches and drug overdose (via syringe and
vaporizer) as frequent problems in anaesthesia. More recent studies show that
the problem is more widespread than previously thought (Table II.5.1). Surveys
in Canada and New Zealand suggest that the vast majority of anaesthetists have
made a medication error at some time during their careers (7,8). Major morbidity
or death were complications in 1.4% of the reported errors. Traditional incident
reporting has been shown to identify only a minority of medication errors (9).
Improved incident monitoring substantially increases the number of identified
errors, but many medication errors are never recognized or reported, and most
studies probably underestimate the extent of the problem (10).
Period
No. of
anaesthesias
No. of drug
errors
6 months
8 312
12
0.14
28 965
31
0.11
1990
16 739
26
0.16
Fasting, Gisvold
(14)
September 1996October
1999
55 426
63
0.11
February 1998October
1999
10 806
81
0.75
21 weeks
6 709
41
0.61
February 1998November
2003
74 478
364
0.49
64
000 perioperative medication errors resulted in harm, including four deaths (18).
This rate is more than three times higher than the percentage of harm in all
MEDMARX records. Children were found to be at higher risk than adults:
nearly 12% of paediatric medication errors resulted in harm. Data from a general
paediatric ward in New Zealand showed a rate as high as one event per four
medication orders, and over 1% of medication orders for children resulted in
preventable harm (9).
Drug infusions are another area of potential risk, as errors occur can during
the mixing of solutions, in calculating concentration and infusion rates and from
co-administration of incompatible drugs through in the same intravenous
cannula (19). As with all drug errors, the consequences of these mistakes are
sometimes serious; even infusions of common opioids have resulted in fatal errors
(1).
While it is difficult to provide a precise overall estimate of the extent of harm
attributable to perioperative medication error, it is almost certain that harmful
errors are grossly underreported. The barriers to reporting are significant. Often,
the only person aware of an error is the one who made it, and motivation to
report the incident may therefore not be high. Given the large number of surgical
procedures performed globally every year, it is likely that the burden of patient
harm from medication errors is substantial. With appropriate safety practices,
many incidents are entirely preventable.
Types of adverse reactions
Adverse drug reactions include allergic reactions, side-effects (e.g. severe
asthmatic response to nonsteroidal anti-inflammatory drugs in susceptible
patients), effects from overdosage or underdosage and harm attributable to
omission of important drugs (such as heparin for cardiopulmonary bypass or
timely antibiotics to prevent infections, as outlined in Objective 6).
Administration of a drug to which the patient is hypersensitive or otherwise at
known risk for an adverse reaction is especially dangerous. This may occur when
the correct drug is given to a patient who has no previous history or allergy; in
such cases, an adverse drug reaction is usually unavoidable. It can also involve
errors of commission despite known hypersensitivity. This can be prevented by
taking a proper history from all patients, adequate documentation and recordkeeping, good communication among members of the clinical care team and the
use of checklists to ensure that the appropriate safety steps are accomplished
efficiently.
Anaphylactic reactions to anaesthetics are estimated to occur in 1:10 000
1:20 000 cases (20). Common causes of anaphylaxis include neuromuscular
blocking drugs, latex, antibiotics, colloids, hypnotics and opioids (21). Crossreactions to drugs may also occur. Patients who have had an anaphylactic
reaction to penicillin are at risk of reacting in the same way to cephalosporins or
imipenem, and a reaction to one type of neuromuscular blocking drug
significantly increases the chances of a reaction to another drug in this class.
Anaphylactic reactions present with a range of signs, including cardiovascular
collapse, bronchospasm, angio-oedema and rash. Most anaphylactic reactions are
immediately evident upon introduction of the offending drug intravenously,
although a full reaction may take 510 min to develop. Management of this lifethreatening emergency includes supportive measures to address cardiovascular
collapse, airway occlusion and bronchospasm. Oxygen, ventilation, intravenous
65
fluids and antihistamines are all recommended in published protocols (22,23).
After elimination of the suspected allergen, treatment should include
epinephrine (adrenaline) to reverse vasodilation and hypotension. Epinephrine
can be titrated intravenously while cardiovascular status is monitored, although
intramuscular administration is possible in a patient without venous access.
The positive outcome of an anaphylactic reaction depends on prompt and
effective treatment. Training of anaesthesia professionals in the management of
these crises is an important aspect of medication safety. A major anaphylactic
reaction in an operating room staffed with trained clinicians and with ready
access to perioperative nursing and technical support is unlikely to result in
death nowadays; the same reaction in an isolated setting with limited resources
and less well trained personnel might result in death.
Most medication errors in anaesthesia involve intravenous bolus
administration, infusion or the administration of gases or vapours, but any route
of administration can be involved. Most fit into the following categories (1,10):
incorrect route: the drug was administered by the wrong route; and
66
error in anaesthesia was an important problem, but most considered that this
was more a problem with the practices of other anaesthesiologists than with their
own (25).
The idiosyncratic nature of the system of medication acquisition, labelling,
storage and administration can contribute to medication errors. Inconsistent
colour-coding, look-alike and sound-alike labelling of different medications and
illegible markings on syringes and ampoules are common problems in hospitals
throughout the world (26). To complicate matters, ampoules of similar
appearance containing different drugs are often stored close together, increasing
the chance of error.
One approach to improving patient safety is to structure a system of
medication delivery that allows clinicians to manage errors rather than focusing
on their elimination. In such a system, practices must be established to reduce
the likelihood of drug error and also to identify errors when they occur, allowing
appropriate steps to be taken to mitigate their consequences. The chance of
dangerous errors can be reduced by simple changes. Colour-coding by class of
drug, for example, can diminish the likelihood of administering a medication with
a similar-sounding name but which has a different effect and mechanism of
action; within-class errors are less likely to cause serious harm than betweenclass errors. Attention should also be focused on particularly dangerous types of
error, such as wrong route of administration or the concentration of a medication
in a solution.
Safe medication delivery implies the consistent administration of the correct
drug to the correct patient in the correct dose at the correct time by the correct
route. Studies evaluating medication errors demonstrate that clinicians
frequently fail to achieve this. In addition to careful practice and conscientious
attention to detail, a systems-based approach to the processes of drug
administration is therefore required.
Recommendations
Highly recommended:
67
Recommended:
Suggested:
References
1. Wheeler SJ, Wheeler DW. Medication errors in anaesthesia and critical care.
Anaesthesia, 2005, 60:25773.
2. Baker GR, et al. The Canadian Adverse Events Study: the incidence of adverse events
among hospital patients in Canada. Canadian Medical Association Journal, 2004,
170:167886.
3. Kohn LT, Corrigan JM, Donaldson MS. To err is human: building a safer health
system. Washington DC, National Acadamy Press, 1999.
4. Bowdle TA. Drug administration errors from the ASA closed claims project. ASA
Newsletter, 2003, 67:113.
5. Cooper JB, et al. Preventable anesthesia mishaps: a study of human factors.
Anesthesiology, 1978, 49:399406.
6. Cooper JB, Newbower RS, Kitz RJ. An analysis of major errors and equipment
failures in anesthesia management: considerations for prevention and detection.
Anesthesiology, 1984, 60:3442.
7. Orser BA, Chen RJ, Yee DA. Medication errors in anesthetic practice: a survey of 687
practitioners. Canadian Journal of Anaesthesia, 2001, 48: 13946.
8. Merry AF, Peck DJ. Anaesthetists, errors in drug administration and the law. New
Zealand Medical Journal, 1995, 108:1857.
9. Kunac DL, Reith DM. Preventable medication-related events in hospitalized children
in New Zealand. New Zealand Medical Journal, 2008, 121:17-32.
10. Webster CS, et al. The frequency and nature of drug administration error during
anaesthesia. Anaesthesia and Intensive Care, 2001, 29:494500.
11. Craig J, Wilson ME. A survey of anaesthetic misadventures. Anaesthesia, 1981,
36:9336.
12. Kumar V, et al. An analysis of critical incidents in a teaching department for quality
assurance. A survey of mishaps during anaesthesia. Anaesthesia, 1988, 43:87983.
68
13. Short TG, et al. Critical incident reporting in an anaesthetic department quality
assurance programme. Anaesthesia, 1993, 48:37.
14. Fasting S, Gisvold SE. Adverse drug errors in anesthesia, and the impact of coloured
syringe labels. Canadian Journal of Anaesthesiology, 2000, 47:10607.
15. Bowdle A, et al. Anesthesia drug administration errors in a university hospital
(Abstract 1358). In: Abstracts of the Meeting of the American Society of
Anesthesiologists, 2003. http://www.asaabstracts.com/ (accessed 4 June 2008).
16. Merry A, et al. Prospective assessment of a new anesthetic drug administration
system designed to improve safety. Anesthesiology, 2006, 105:A138.
17. Stabile M, Webster CS, Merry AF. Medication administration in anaesthesia. Time
for a paradigm shift. APSF Newsletter, 2007, 22:446.
18. United
States
Pharmacopeia.
MEDMARX
data
http://www.usp.org/products/medmarx (accessed 12 April 2008).
report,
2007.
19. Khan FA, Hoda MQ. A prospective survey of intra-operative critical incidents in a
teaching hospital in a developing country. Anaesthesia, 2001, 56:17782.
20. Fisher MM, Baldo BA. The incidence and clinical features of anaphylactic reactions
during anesthesia in Australia. Annales franaises d'anesthsie et de ranimation,
1993, 12:97104.
21. Mertes PM, Laxenaire MC, Alla F. Anaphylactic and anaphylactoid reactions
occurring during anesthesia in France in 19992000. Anesthesiology, 2003, 99:536
45.
22. Association of Anaesthetists of Great Britain and Ireland and British Society for
Allergy and Clinical Immunology. Suspected anaphylactic reactions associated with
2003.
anaesthesia.
http://www.aagbi.org/publications/guidelines/docs/anaphylaxis03.pdf (accessed 12
April 2008).
23. Kroigaard M, et al. Scandinavian clinical practice guidelines on the diagnosis,
management and follow-up of anaphylaxis during anaesthesia. Acta
Anaesthesiologica Scandinavica, 2007, 51:65570.
24. Jensen LS, et al. Evidence-based strategies for preventing drug administration errors
during anaesthesia. Anaesthesia, 2004, 59:493504.
25. Webster CS, Grieve DJ. Attitudes to error and patient safety. Prometheus, 2005,
23:25363.
26. Webster CS, Anderson D, Murtagh S. Safety and peri-operative medical care.
Anaesthesia, 2001, 56:4967.
69
Objective 6: The team will consistently use methods known to minimize the risk
for surgical site infection.
An infection that occurs in surgical patients at the site of operation is known
as surgical site infection. These infections occur after invasive procedures in the
superficial or deep layers of the incision or in the organ or space that was
manipulated or traumatized, such as the peritoneal space, pleural space,
mediastinum or joint space. These problems are serious and costly, and are
associated with increased morbidity and mortality as well as with prolonged
hospitalization (13). Recently, their prevalence has been used as a marker for
the quality of surgeons and hospitals (47).
Surgical site infection accounts for about 15% of all health-care-associated
infections and about 37% of the hospital-acquired infections of surgical patients
(8,9). Two thirds of surgical site infections are incisional and one third confined to
the organ space (9). In western countries, the frequency of such infections is 15
20% of all cases, with an incidence of 215% in general surgery (3,1012).
Surgical site infections lead to an average increase in the length of hospital stay
of 47 days. Infected patients are twice as likely to die, twice as likely to spend
time in an intensive care unit and five times more likely to be readmitted after
discharge (11,1315).
Health-care costs increase substantially for patients with surgical site
infections. The severity of the effects depends on the extent of the surgical
procedure, the country and the method used to calculate costs (3,12,1618). In
the United States, at least 780 000 surgical site infections occur each year, with
rates as high as 13% for high-risk colon surgery (19,20). Such infections resulted
in 3.7 million excess hospital days and US$ 1.63 billion in excess hospital costs
per year (15,21). In the United Kingdom, the excess cost has been calculated to be
about 1594 per infection (3). In the European Union, surgical site infections
exact an economic toll of 1.519.1 billion per year (12). The prevalence and
consequences of surgical site infections are illustrated in Tables II.6.1 and II.6.2.
Study period
Study design
Surgical site
infections
No.
Australia (26)
Hospitals (28)
1992
Retrospective
5 432
7.9
Brazil (27)
19931998
Retrospective
9 322
6.8
France (24)
19982000
Prospective
26 904
3.3
Italy (23)
Prospective
6 167
3.3
Spain (25)
19921994
Prospective
1 483
10.5
Thailand (29)
1992
Prevalence
15 319
2.7
Thailand (30)
20032004
Prospective
4 764
1.4
19921998
Prospective
738 398
2.6
1999
Prospective
697
10.9
70
Type of operation
Consequence studied
Heart
Length of postoperative
stay
21 days
Length of postoperative
stay; cost
Gastrointestinal, orthopaedic,
gynaecology
Length of postoperative
stay
8.5 days
Length of postoperative
stay; cost
All surgery
Length of postoperative
stay
6 days
All surgery
Length of postoperative
stay; mortality
5 days; 4.3%
All surgery
Length of postoperative
stay
1 day
Cost
UK 1618
Orthopaedic
Cost
US$ 17 708
Other factors that affect the probability of infection are depicted in the
following hypothetical equation (36):
Inoculum
Virulence
Adjuvant
of bacteria +
of bacteria +
effects
------------------------------------------------------------------Innate and adoptive _
Acute and chronic
host defence
host liabilities
= Probability of infection
71
Bacterial contamination is a necessary precursor to surgical site infection.
Skin bacteria are always present, despite thorough skin preparation. In addition,
numerous bacteria contaminate any operation involving a body structure
ordinarily colonized by bacteria, such as the bowel. Quantitatively, the risk for
surgical site infection is markedly increased if the surgical site is contaminated
with > 105 microorganisms per gram of tissue (38); however, the dose of
contaminating microorganisms required to produce infection might be much
lower when foreign material is present at the surgical site (e.g. 100 staphylococci
per gram of tissue introduced on silk sutures).
The aggressiveness of many invasive microorganisms is often a function of
their biology. Many bacteria that cause surgical site infections contain or produce
toxins and other substances that increase their ability to survive on or in host
tissue and invade and damage the host. The more virulent the bacterial
contaminant, the greater the probability of infection.
Some bacterial surface components, notably polysaccharide capsules, inhibit
phagocytosis, a critical and early host defence response to microbial
contamination. Certain strains of clostridia and streptococci produce potent
exotoxins that disrupt cell membranes or alter cellular metabolism (39). A
variety of microorganisms, including Gram-positive bacteria such as coagulasenegative staphylococci, produce glycocalyx and an associated component called
slime, which physically shields bacteria from phagocytes or inhibits the binding
or penetration of antimicrobial agents (40). Although these and other virulence
factors are well defined, their mechanistic relationship to surgical site infection
has not been fully determined.
The source of the pathogens that cause most surgical site infections is the
endogenous flora of the patients skin, mucous membranes or hollow viscera.
When a mucous membrane or skin is incised, the exposed tissues are at risk for
contamination. The organisms are usually aerobic Gram-positive cocci (e.g.
staphylococci) but may include faecal flora (e.g. anaerobic bacteria and Gramnegative aerobes) when the incision is made near the perineum or groin. When a
gastrointestinal organ is opened during an operation and is the source of
pathogens, Gram-negative bacilli (e.g. Escherichia coli), Gram-positive organisms
(e.g. enterococci) and sometimes anaerobes (e.g. Bacteroides fragilis) are the
typical isolates.
Bacterial contaminants may also enter the wound from exogenous sources,
including the air in the operating room, instruments, prostheses or other
implants or the surgical team that comes into contact with the wound (4144).
The exogenous flora are primarily aerobes, especially Gram-positive organisms
(e.g. staphylococci and streptococci). Fungi from endogenous and exogenous
sources rarely cause surgical site infections, and their pathogenesis is not well
understood (45,46).
Pathogens isolated from the surgical site vary according to the type of surgery
as well as the organ and location. The distribution of pathogens isolated from the
surgical site in the National Nosocomial Infections Surveillance (NNIS) system in
the United States between 1986 and 1996 is shown in Table II.6.3. The pathogen
most frequently isolated was Staphylococcus aureus, followed by coagulasenegative staphylococci, Enterococcus spp., E. coli and Pseudomonas aeruginosa.
There was a notable increase over this time period in antimicrobial-resistant
pathogens, such as methicillin-resistant S. aureus and fungal pathogens,
especially Candida albicans (46,47). This increase might reflect inappropriate use
72
of antimicrobial medication because not all specimens can be sent to laboratories
for isolation of pathogens, and some pathogens are difficult to identify in some
laboratories. Moreover, some surgeons prefer to use broad-spectrum antibiotics
instead of drugs with a narrower susceptibility profile (48). The increase in
fungal pathogens might also reflect an increase in the number of
immunocompromised surgical patients.
Percentage of isolates
19861989
19901996
(n = 16 727)
(n = 17 671)
Staphylococcus aureus
17
20
Coagulase-negative staphylococci
12
14
Enterococcus spp.
13
12
Escherichia coli
10
Pseudomonas aeruginosa
Enterobacter spp.
Proteus mirabilis
Klebsiella pneumonia
Candida albicans
Bacteroides fragilis
73
control of hyperglycaemia;
74
Not all studies, however, show a reduction in surgical site infection rates after
continuous surveillance. Standardized definitions of infection and objective
criteria should be used whenever possible. The most widely used definition is
that of the NNIS system of the Centers for Disease Control and Prevention in the
United States (61).
Definitions of surgical site infection
A precise definition of surgical site infection is vital for personnel measuring
infection rates. It should be simple and accepted by nurses and surgeons. Use of a
standard definition allows comparison of rates across surgeons and hospitals. In
the NNIS definition, surgical site infection is divided into two main groups,
incisional and organspace. Incisional infections are further subdivided into
superficial (skin and subcutaneous tissue) and deep (deep soft tissue such as
fascia and muscle layers). Organspace surgical site infection involves any part
of the anatomy other than the incision that is opened or manipulated during an
operation (Figure 6.1). The criteria for the different sites of infection are given
below.
Superficial incisional surgical site infection: Infection occurs at the incision site
within 30 days of surgery and involves only skin or subcutaneous tissue at the
incision and at least one of the following:
75
The following conditions are generally not reported as surgical site infection:
Deep incisional surgical site infection: Infection occurs at the site of operation
purulent drainage from deep incision but not from the organspace
component of the surgical site;
purulent drainage from a drain placed through a stab wound into the
organspace;
76
Table II.6.4 Point scale for daily wound inspection for ASEPSIS scoring of
surgical site infections
Wound characteristic
Serous exudates
Erythema
Purulent exudates
Separation of deep tissue
< 20
2039
4059
6079
80
0
0
0
0
1
1
2
2
2
2
4
4
3
3
6
6
4
4
8
8
5
5
10
10
The point scales for additional information on wound treatment, culture findings and delayed
discharge are:
a) antibiotic therapy for wound infection (additional treatment): not given = 0, given = 10
b) drainage of pus under local anesthesia (additional treatment): not done = 0, done = 5
c) debridement of wound under general anesthesia (additional treatment): not done = 0, done = 10
d) isolation of pathogenic bacteria: none = 0, present = 10
e) stay as inpatient: not prolonged = 0, prolonged = 5
ASEPSIS scores range from 0 to 70, with the following interpretation: 010,
satisfactory healing; 1120, disturbance of healing; 2130, minor wound
infection; 31 40; moderate wound infection; > 40, severe wound infection.
The risk index in the Study on the Efficacy of Nosocomial Infection Control
(SENIC) is based on four clinical findings: abdominal operation, operation lasting
more than 2 hours, surgical wound classed as contaminated, dirty or infected,
and patient with three or more major pre-existing diagnoses (66). Each clinical
finding adds one point to the total score, the minimum index value being 0 and
the maximum 4; 0 denotes a low risk for surgical site infection, 1 point implies an
intermediate risk, and 24 points indicate a high risk. While the SENIC risk
77
index is valid as a scoring system, it has not been popular because of the constant
2-hour cut-off point for the duration of the operation.
The NNIS risk index was based on the SENIC index (66), with three
parameters: the American Society of Anesthesiologists (ASA) preoperative
assessment classification, reflecting the patients preoperative physical status;
the duration of the procedure; and the surgical wound class. One point is scored
for each finding: an ASA preoperative assessment classification of 3, 4 or 5;
duration of surgery longer than 75% of similar cases; and a surgical wound
classed as contaminated, dirty or infected. If a procedure is performed
endoscopically, the NNIS risk index score is modified by subtracting one point;
therefore, the NNIS risk index ranges from 1 to 3. An index of 0 is interpreted
as a low risk for surgical site infection, an index of 1 means an intermediate risk,
and an index of 2 or 3 equates to a high risk. The NNIS risk index is popular
because it includes the specific duration of the operation being performed and
replaces the severity of underlying disease in the SENIC risk index by the ASA
classification. Moreover, it shows a linear trend with both crude and adjusted
rates of surgical site infection. The NNIS risk index has therefore been applied to
benchmarked surgical site infection rates by indirect standardization and
reported in terms of a standardized infection ratio (24,6770). This ratio can be a
useful tool for comparing surgical site infection rates between institutions (30).
The NNIS risk index has been shown to be more accurate than the simple
preoperative wound classification of clean, cleancontaminated, contaminated
and dirty described by the Centers for Disease Control and Prevention in the
United States (see Antibiotic prophylaxis below).
Surveillance of surgical site infections
Surveillance has been described as the on-going systematic collection,
analysis, evaluation and dissemination of data. Monitoring systems use
assessement criteria based on standard definitions, extent of coverage,
adjustment for risk, ability to collect and validate data, ability to analyse data
and provide feedback to clinicians, and wider dissemination to academic and
clinical personnel (65,71). An active surveillance programme is necessary for
accurate identification of surgical site infections (72).
The methods used for surveillance of surgical site infections were originally
designed for monitoring inpatients only. Over the past decade, the shift from
inpatient to outpatient surgical care has been dramatic (73), making traditional
surveillance methods considerably more difficult to employ. Most hospitals do not
have the resources to monitor all surgical patients all the time; therefore, they
should target their efforts to high-risk procedures and combine computerassisted, laboratory-based screening with case confirmation by surgeons
(10,30,53,67,68,70,74). When the necessary technology is available, these
methods can be reliable, accurate and less time-consuming than conventional
methods of chart review.
Inpatients: Several methods have been used to identify inpatients with surgical
site infections. Direct observation of the surgical site by the surgeon, a trained
nurse or infection control personnel, and indirect detection by infection control
personnel who review laboratory reports, patient records and hold discussions
with primary-care providers are two of the most common strategies (38). Direct
78
observation of surgical sites is the most precise and accurate method for
detecting surgical site infections (10), but several studies have utilized indirect
methods (75,76). Because the hospital stay is often very short, post-discharge
surveillance has become increasingly important to obtain precise infection rates.
Risk factors
Patient characteristics and comorbidity play an important role in determining
the likelihood of infection after surgery. Coincident remote-site infections,
colonization (in particular, nares colonization with S. aureus), diabetes, cigarette
smoking, use of systemic steroids, obesity (body mass index 30 kg/m2), extremes
of age, poor nutritional status, perioperative blood transfusion and prolonged
preoperative stay have all been shown to increase the risk of surgical site
infection (42,43,83102). Prolonged postoperative hospital stay has also been
frequently associated with increased surgical site infection risk (52,103,104).
Length of stay is, however, probably a surrogate for severity of illness and
comorbid conditions requiring inpatient work-up or therapy before or after the
operation.
The characteristics of the operation can also affect the likelihood of surgical
site infection. Preoperative preparation has a demonstrable role in preventing
infection. Antiseptic showering, clipping (as opposed to shaving) for hair removal,
skin preparation and hand and forearm scrub antisepsis are steps that can
reduce infection rates. Several studies have shown that preoperative hair
removal by any means is associated with increased surgical site infection rates
and have suggested that no hair be removed (38,105,106). Appropriate antiseptic
agents, scrubbing technique and duration of the scrub (both of the patients skin
and of the hands and forearms of the surgical team) result in decreased bacterial
colony counts (107111), although these practices have not been shown
definitively to reduce surgical site infection rates (112,113).
Intraoperative factors such as the operating room environment (appropriate
ventilation and cleanliness of environmental surfaces), sterilization of
instruments, designated surgical attire (including masks, caps and shoe covers)
and sterile drapes and scrub suits (including sterile gloves and gowns) also
increase the likelihood of reducing contamination of the surgical wound.
Antibiotic prophylaxis has the most evidence to support its use in the prevention
79
of surgical site infection. When used appropriately, infection rates can be
significantly reduced (see Antibiotic prophylaxis below).
The two most important principles of infection prevention, however, are
related to the duration of the operation and the surgical aseptic technique
(114,115). Minimizing the amount of time required for surgery is considered to be
one of the principle means of preventing infections. Lack of adherence to the
principles of asepsis during procedures has been associated with outbreaks of
postoperative infections (116). Meticulous surgical technique is widely considered
to reduce the risk for surgical site infection, and includes maintaining effective
haemostasis while preserving an adequate blood supply, preventing
hypothermia, handling tissues gently, avoiding inadvertent entries into a hollow
viscus, removing devitalized tissue, using drains and suture material
appropriately and eradicating dead space (117119).
Appropriate postoperative management of the incision can reduce surgical
site infection. The type of care is determined by whether the incision is closed or
left open to heal by secondary intention. The evidence is inconclusive as to
whether an incision should be covered with a dressing or whether showering or
bathing is detrimental to healing. However, when a surgical incision is left open
at the skin level for a few days before it is closed (delayed primary closure), the
incision should be packed with sterile moist gauze and covered with a sterile
dressing (110) or a hydrofibre dressing (120,121).
Blood glucose and risk of infection: Patients with diabetes have long been
Oxygen tension and temperature in the perioperative period: All surgical wounds
contain at least some bacteria at the end of the procedure (35). The balance
between the number and virulence of bacteria and the resilience of host defences
determines whether a surgical site infection will result. One of the key host
defences is the action of leukocytes in the wound. White cells use activated
oxygen to kill bacteria, and a number of studies in vitro and in experimental
80
animals have shown the importance of oxygen tension in supporting this process
(131135). Subsequent studies of postoperative patients showed that the risk for
surgical site infection was associated with subcutaneous oxygen tension at the
wound (136). Tissue warming improves tissue perfusion and tissue oxygen
tension (137).
A multicentre trial in Europe of patients who had undergone colectomy
showed that maintaining normothermia during the operation reduced the rate of
infection (138), while a trial in the United Kingdom of smaller operations (on the
breast, hernias and varicose veins) showed a lower infection rate when patients
were warmed before the operation (139). Perioperative morbid cardiac events are
also reduced by maintaining normothermia during major operations (140).
The benefit of increasing the level of inspired oxygen during surgery in order
to increase tissue oxygen tension is less clear cut than that of maintaining
normothermia. Three prospective randomized trials of patients undergoing
colectomy or other major intra-abdominal procedures compared administration of
an 80% or 3035% fraction of inspired oxygen during the operation and for 26
hour afterwards (141143). The first and third trials showed a benefit and the
other trial showed an increased infection rate with a higher fraction of inspired
oxygen. The two trials showing benefit were better designed and had more
patients, but no conclusion can yet be drawn (144,145). Yet increasing the
fraction of inspired oxygen might be beneficial and is almost certainly not
harmful. Risk factors associated with surgical site infection are listed in Table
II.6.5.
Table II.6.5 Patient and operation characteristics that may be associated with
surgical-site infection
Patient characteristic
Operation characteristic
Age
Nutritional status
Diabetes
Smoking
Obesity
Colonization with microorganisms
Coexisting infection at a remote body
site
Altered immune response
Length of preoperative stay
81
isolated even after three applications of agents such as iodinealcohol to the skin
(147).
The United States Food and Drug Administration defines a skin disinfectant
as a fast acting, broad-spectrum and persistent antiseptic-containing
preparation that significantly reduces the number of microorganisms on intact
skin (148). There is no clear-cut level of bacterial skin load that should be
removed or killed before surgery, and 80% of bacteria in surgical site infections
originate from the skin of the patient (149). Therefore, the Food and Drug
Administration and authorities in Europe and elsewhere have set standards that
a disinfectant for presurgical skin preparation must meet before it can be legally
marketed. The Food and Drug Administration requires testing at both 10
minutes and 6 hours: disinfectants should reduce colony-forming units (CFU) by
more than 2 log10 at dry sites (e.g. abdominal skin) and by 3 log10 at moist sites
(e.g. groin).
Most guidelines recommend a scrub-paint technique for applying a
disinfectant. One study indicated, however, that spraying might be sufficient
(150). The number of bacteria expected at a surgical site ultimately determines
the number of disinfectant applications. As a general rule, three application are
sufficient; however, in areas with high densities of bacteria, this might not be
sufficient to kill all vegetative bacteria (151).
Before a patients skin is prepared for a surgical procedure, it should be
cleansed of gross contamination (e.g. dirt, soil or any other debris) (38). Although
preoperative showering has not been shown to reduce the incidence of surgical
site infection, it might decrease bacterial counts and ensure that the skin is clean
(152). The antiseptics used to prepare the skin should be applied with sterile
supplies and gloves or by a no-touch technique, moving from the incision area to
the periphery (38). The person preparing the skin should use pressure, because
friction increases the antibacterial effect of an antiseptic. For example, alcohol
applied without friction reduces bacterial counts by 1.01.2 log10 CFU compared
with 1.93.0 log10 CFU when friction is used. Alcoholic sprays have little
antimicrobial effect and produce potentially explosive vapours (153).
Alcoholic compounds: For centuries, alcohols have been used for their
82
specific cellular functions (154). Ethanol and isopropanol at appropriate
concentrations have broad spectra of antimicrobial activity that include
vegetative bacteria, fungi and viruses. Their antimicrobial efficacies are
enhanced in the presence of water, with optimal alcohol concentrations being 60
90% by volume.
Alcohols such as 7080% ethanol kill vegetative bacteria such as S. aureus,
Streptococcus pyrogenes, Enterobacteriaceae and Ps. aeruginosa in 1090 s in
suspension tests (155). Isopropanol is slightly more bactericidal than ethanol
(154) and is highly effective against vancomycin-resistant enterococci (156). It
also has excellent activity against fungi such as Candida spp., Cryptococcus
neoformans, Blastomyces dermatitidis, Coccidioides immitis, Histoplasma
capsulatum, Aspergillus niger and dermatophytes and mycobacteria, including
Mycobacterium tuberculosis. Alcohols generally do not, however, destroy
bacterial spores, and fatal infections due to Clostridium species have occurred
when alcohol was used to sterilize surgical instruments.
Both ethanol and isopropanol inactivate most viruses with a lipid envelope
(e.g. influenza virus, herpes simplex virus and adenovirus). Several investigators
found that isopropanol had less virucidal activity against naked, nonenveloped
viruses (157). In experiments by Klein and DeForest (158), 2-propanol, even at
95%, did not inactivate nonenveloped poliovirus type 1 or coxsackievirus type B
within 10 min, whereas 70% ethanol inactivated these enteroviruses. Neither
70% ethanol nor 45% 2-propanol killed hepatitis A virus when their activities
were assessed on stainless-steel discs contaminated with faecally suspended
virus. Of the 20 disinfectants tested, only three reduced the titre of hepatitis A
virus by more than 99.9% in 1 min (2% glutaraldehyde, sodium hypochlorite with
> 5000 ppm free chlorine, and a quaternary ammonium formulation containing
23% HCl) (159). Bond et al. (160) and Kobayashi et al. (161) showed that 2propanol (70% for 10 min) or ethanol (80% for 2 min) rendered human plasma
contaminated with hepatitis B virus at high titre non-infectious for susceptible
chimpanzees. Both 15% ethanol and 35% isopropanol readily inactivated human
immunodeficiency virus (HIV), and 70% ethanol rapidly inactivated high titres of
HIV in suspension, independent of the protein load (162). The rate of inactivation
decreased when the virus was dried onto a glass surface and high levels of
protein were present (163). In a suspension test, 40% propanol reduced the
rotavirus titre by at least 4 log10 in 1 min, and both 70% propanol and 70%
ethanol reduced the release of rotavirus from contaminated fingertips by 2.7 log10
units (164), whereas the mean reductions obtained with liquid soap and an
aqueous solution of chlorhexidine gluconate were 0.9 and 0.7 log10 units,
respectively (165).
Alcohol is thus the most widely used skin disinfectant. Alcohols used for skin
disinfection before invasive procedures should be free of spores; although the risk
of infection is minimal, the low additional cost for a spore-free product is
justified. One study indicated that isopropanol in a commercial hand rub could be
absorbed dermally, transgressing the religious beliefs of some health-care
workers (166), although the results have been put into question by a recent trial
(167). WHO resolved the issue in their most recent guidelines on hand hygiene by
carefully analysing the available information and concluding that use of alcoholic
compounds for patient care does not transgress religious beliefs (168). Alcoholic
compounds are not suitable for use during surgery at or in close proximity to
mucous membranes or the eyes.
83
Chlorhexidine formulations are used extensively for surgical and hygienic hand
disinfection; other applications include preoperative showers (or whole-body
disinfection), antisepsis in obstetrics and gynaecology, management of burns,
wound antisepsis and prevention and treatment of oral disease (plaque control,
pre- and postoperative mouthwash, oral hygiene). When chlorhexidine is used
orally, its bitter taste must be masked, and it can stain the teeth. Intravenous
catheters coated with chlorhexidine and silver sulfadiazine are used to prevent
catheter-associated bloodstream infections (171).
Chlorhexidine is most commonly formulated as a 4% aqueous solution in a
detergent base; however, alcoholic preparations have been shown in numerous
studies to have better antimicrobial activity than detergent-based formulations
(172). Bactericidal concentrations destroy the bacterial cell membrane, causing
cellular constituents to leak out of the cell and the cell contents to coagulate
(169). The bactericidal activity of chlorhexidine gluconate against vegetative
Gram-positive and Gram-negative bacteria is rapid. In addition, it has a
persistent antimicrobial action that prevents regrowth of microorganisms for up
to 6 hours. This effect is desirable when a sustained reduction in microbial flora
reduces the risk for infection, such as during surgical procedures. Chlorhexidine
has little activity against bacterial and fungal spores except at high
temperatures. Mycobacteria are inhibited but are not killed by aqueous solutions.
Yeasts and dermatophytes are usually susceptible, although the fungicidal action
varies with the species (173). Chlorhexidine is effective against lipophilic viruses,
such as HIV, influenza virus and herpes simplex virus types 1 and 2, but viruses
like poliovirus, coxsackievirus and rotavirus are not inactivated (169). Blood and
other organic material do not affect the antimicrobial activity of chlorhexidine
significantly, in contrast to their effects on povidoneiodine (153). Organic and
inorganic anions such as soaps are, however, incompatible with chlorhexidine,
and its activity is reduced at extremely acidic or alkaline pH and in the presence
of anionic- and nonionic-based moisturizers and detergents.
84
High concentrations of chlorhexidine and preparations containing other
compounds, such as alcohols and surfactants, may also damage the eyes, and its
use on such tissues is not recommended (180).
85
women or to newborns and infants (181). Because severe local and systemic
allergic reactions have been observed, iodophors and iodine should not be used in
patients with allergies to these preparations (189). Iodophores have little if any
residual effect; however, they may have residual bactericidal activity on the skin
surface for a limited time, because free iodine diffuses into deep regions and also
back to the skin surface (182). The antimicrobial efficacy of iodophors is reduced
in the presence of organic material such as blood.
Irgacare MP) has been used for more than 30 years in a wide array of skin-care
products, including handwashes, surgical scrubs and consumer products. A
review of its effectiveness and safety in health-care settings has been published
(190). A concentration of 1% has good activity against Gram-positive bacteria,
including antibiotic-resistant strains, but is less active against Gram-negative
organisms, mycobacteria and fungi. Limited data suggest that triclosan has a
relatively broad antiviral spectrum, with high-level activity against enveloped
viruses such as HIV-1, influenza A virus and herpes simplex virus type 1. The
nonenveloped viruses proved more difficult to inactivate.
Clinical strains of bacteria resistant to triclosan have been identified, but the
clinical significance remains unknown (191). Triclosan is added to many soaps,
lotions, deodorants, toothpastes, mouth rinses, commonly used household fabrics,
plastics and medical devices. The mechanisms of triclosan resistance may be
similar to those involved in antimicrobial resistance (192), and some of these
mechanisms may account for the observed cross-resistance of laboratory isolates
to antimicrobial agents (193). Consequently, concern has been raised that
widespread use of triclosan formulations in non-health-care settings and
products might select for biocide resistance and even cross-resistance to
antibiotics. Environmental surveys have not, however, demonstrated an
association between triclosan use and antibiotic resistance (194).
Triclosan solutions have a sustained residual effect against resident and
transient microbial flora, which is minimally affected by organic matter. No toxic,
allergenic, mutagenic or carcinogenic potential has been identified in any study.
Triclosan formulations can help control outbreaks of methicillin-resistant S.
aureus when used for hand hygiene and as a bathing cleanser for patients (190),
although some methicillin-resistant S. aureus isolates have reduced triclosan
susceptibility. Triclosan formulations are less effective than 24% chlorhexidine
gluconate when used as surgical scrub solutions, but properly formulated
triclosan solutions can be used for hygienic hand washing.
86
has a marked residual effect. No toxicological problems were found when the
0.1% formulation was applied according to the manufacturers recommendations.
The colourless solution is a useful antiseptic for mucous membranes of the female
and male genital tracts and the oral cavity, but its unpleasant taste limits its use
orally (197). In a recent observational study, the 0.1% formulation was highly
effective and well tolerated in the care of central venous catheter insertion sites
(198), and the results of this study are supported by those of a randomized
controlled clinical trial (199). Octenidine is not registered for use in the United
States.
Table II.6.6 lists antimicrobial agents that are recommended for surgical
skin preparation.
Comment
6090% isopropanol
7.510% povidineiodine
24% chlorhexidine
Iodine, 3% preparation
para-Chlorometaxylenol (PCMX)
Vaginal and uterine surgery: Endometritis and wound infection are common
significant postoperative complications of vaginal surgery, with reported
infection rates varying between 5% and > 50%. The best-recognized risk factors
for post-caesarean endometritis involve the introduction of large quantities of
bacteria from the vagina and cervix into the uterine cavity. Therefore, reducing
bacterial contamination of the vagina and cervix by vaginal swabbing with
povidoneiodine solution before caesarean section is a reasonable approach. In
one study, this led to a significant decline in the rate of postoperative
endometritis (200); however, a randomized controlled trial failed to demonstrate
an effect (201). Vaginal decontamination may be particularly useful in indigent
patients or in settings where the bioburden of the vagina might be high.
Digestive-tract surgery: Selective decontamination of the digestive tract has been
recommended for decades to decrease the rates of postoperative pneumonia and,
to a lesser extent, surgical site infections (202). These effects should, however, be
balanced against the cost, workload and risk for the emergence of multiresistant
pathogens. Several recent trials indicates that a mouth rinse with chlorhexidine
had a similar effect to selective decontamination of the digestive tract in patients
undergoing cardiac surgery (203205).
87
Antibiotic prophylaxis
Before the late 1960s, most prophylactic antibiotics were administered after
the end of a surgical procedure and were therefore found to be ineffective.
Patients who received antibiotics had a higher rate of infection than patients who
did not, probably because they were administered ineffectively and given only
when the surgeon recognized an increased risk (207). Classic experiments in
animals by John Burke demonstrated the sequence of events that occur in a
surgical incision before infection and the importance of administering the
antibiotic before wound contamination occurs (208,209). Subsequent placebocontrolled trials in humans showed a significant reduction in surgical site
infections when antibiotics were used preoperatively. One prospective trial
indicated that starting antibiotics before the immediate preoperative period was
not beneficial (210), and a large retrospective examination of the time of
antibiotic administration showed an increase in surgical site infection rates when
antibiotics were given more than 2 hours before incision or after the incision
(211). Initially, prophylactic antibiotics were given when the patients were called
to the operating room, but subsequent studies showed that intravenous
administration immediately before (average, 20 minutes) anaesthesia induction
achieved better serum and tissue levels both at the beginning and at the end of
the operation (212 and J. DiPiro, personal communication). DiPiro found that
cefazolin given on average 17 minutes (729) before incision achieved an average
tissue level of 76 mg/l, while cefoxitin given 22 minutes (1345) before incision
achieved an average tissue level of 24 mg/l. The interval between being called to
the operating room and the start of most operations is highly variable, and this
unpredictable interval leads to an extended delay between delivery of antibiotics
and skin incision. Consequently, the tissue levels of antibiotic are often less than
ideal at the start of the operation. A recent review of total joint arthroplasty
operations in the Netherlands confirmed the importance of preoperative
administration of prophylactic antibiotics and showed that the lowest infection
rate was associated with administration within 30 minutes of incision (213,214).
Vancomycin is one of the few antibiotics that require adjustments in timing;
commencement of infusion should be timed such that completion is achieved
within an hour of incision (215,216).
There is widespread agreement and good evidence to support the use of
prophylactic antibiotics before all gastrointestinal (including appendicitis),
oropharyngeal, vascular (including abdominal and leg), open-heart and obstetric
and gynaecological procedures, orthopaedic prosthesis placement, spinal
operations, craniotomy and even some clean procedures (217,218). The typical
reductions in infection rates seen in early placebo-controlled trials of prophylaxis
are shown in Table II.6.7. While there is some controversy about the use of
prophylactic antibiotics for designated clean operations, it is well accepted for
open-heart operations, joint replacement, vascular prostheses and craniotomy in
which the absolute number of infections is low but the consequence of any
infection is severe (Table II.6.8). The reduction in infection rate is similar for
other clean procedures (219222), but the absolute number of infections
prevented is lower when the underlying infection rate is lower (220,223). If the
number of administrations of routine prophylaxis needed to prevent one infection
is high, the morbidity of the infection should be high, or the cost, both financial
and medical, of the prophylaxis should be low.
88
Table II.6.7 Typical rates of infection and reduction with prophylaxis in
placebo-controlled trials
Operation (reference)
Prophylaxis (%)
Placebo (%)
Colon (224227)
412
2448
35
46
1529
49
Vascular (232,233)
14
717
1017
Cardiac (234,235)
39
4449
23
Hysterectomy (236)
116
1838
36
Craniotomy (237239)
0.53
412
929
2.2
5.9
27
0.51
29
12100
3.5
5.2
58
Spinal (240)
Total joint replacement (241,242)
Breast and hernia (221)
Few studies have examined the ideal dose of prophylactic antibiotics. A study
of morbidly obese patients showed a two-thirds reduction in surgical site
infection rates when the dose of cefazolin was increased from 1 g to 2 g (243).
Early trials involving patients undergoing cardiac surgery demonstrated a
correlation between risk for infection and absence of antibiotic in the serum at
the end of the operation (244) and low levels of antibiotics at the time of
cannulation (245). In a study of prophylaxis in patients undergoing colectomy,
the strongest association with avoidance of surgical site infection was the level of
drug in the serum at the end of the operation (246). Repeated administration of
the drug at one to two half-lives or use of a drug with a long half-life during
lengthy operations also reduced infection rates (247,248). Thus, the most
89
important aspect in the timing and dosing of prophylactic antibiotics is achieving
effective levels throughout the time that the incision is open.
Early trials of antibiotic prophylaxis usually involved a three-dose regimen,
with the first and last dose separated by 12 hours. Within a short time, many
placebo-controlled trials demonstrated the efficacy of a single preoperative dose
of prophylactic antibiotic. Nevertheless, the practice of continuing prophylactic
antibiotics postoperatively, often for days, is widespread. For example, there is no
evidence to support the common practice of using prophylactic antibiotics until
all central lines and drains have been removed. Many trials in which shorter
duration of prophylaxis was compared with longer failed to show any benefit of
longer duration (249251). Other studies show that more resistant bacteria are
recovered from patients who receive prophylaxis for a long time (252). An expert
panel assembled by the United States Center for Medicare and Medicaid Services
recommended that prophylactic antibiotics be initiated during the 60 minutes
before incision and stopped within 24 hours of the end of the operation (14).
Many different antibiotics have been shown to reduce the incidence of
surgical site infections. The primary consideration is that the antibiotic used is
active against the spectrum of bacteria commonly encountered during the
procedure and recovered from surgical site infections. There is general agreement
that the antibiotic agents used for prophylaxis should be different from those
usually chosen for first-line treatment of established infections, although this
supposition has never been studied systematically. A number of societies and
organizations, including the Surgical Infection Society (218), the Infectious
Diseases Society of America (217), the American Society of Hospital Pharmacists
(253), Johns Hopkins University (254), the Medical Letter (255) and the Scottish
Intercollegiate Guidelines Network (256), have published well-researched
guidelines and recommendations for surgical antibiotic prophylaxis.
Table II.6.9 gives recommendations published by various professional
societies and organizations. Usually, a single first-generation cephalosporin for
operations not expected to encounter anaerobes or a single second-generation
cephalosporin with anaerobic activity for anaerobic operations based on local
susceptibility patterns is sufficient. For clean operations on the skin and
subcutaneous tissues that do not involve any portion of the gastrointestinal tract,
a semi-synthetic penicillin resistant to penicillinases, such as oxacillin or
cloxacillin, is probably effective, although there are limited published data to
support this recommendation. Administration of antibiotics that are active
against enteric anaerobes for procedures involving the lower gastrointestinal
tract should be considered routine. Procedures on the upper gastrointestinal tract
should involve use of antibiotics with activity against Gram-positive cocci and
common Gram-negative organisms but which are not active against anaerobes.
Procedures that do not enter any portion of the intestinal or genitourinary tract
are sufficiently covered with antibiotics that are primarily active against Grampositive cocci.
90
Agents
Colectomy
Other gastrointestinal
surgery
Hysterectomy
Not all agents listed have been tested in prospective placebo-controlled trials, but most are widely used
and fulfill the criterion of being active against the usual pathogens encountered in these settings.
a
The recommendations for metronidazole and clindamycin combined with various Gram-negative
agents as listed above have had limited or no testing but represent logical choices on the basis of
antibiotic susceptibility patterns and known colonic flora. In addition, they have all been used
successfully in the treatment of infections originating in the colon.
b
Procedures of the stomach and pancreatic and biliary systems are managed with any of these agents.
Distal ileal and appendix operations are more appropriately managed with the agents listed for
colectomy.
c
Early studies showed no difference between agents with (cefotetan, cefoxitin) and without (cefazolin,
cefuroxime) anaerobic activity. More recent trials demonstrate better results with agents active against
anaerobes.
91
Prophylaxis for caesarean section: Caesarean section, one of the most commonly
been done in paediatric populations, but the issue has been reviewed by the
American Academy of Pediatrics (263), which concluded that the basic biological
principles of prophylaxis are unlikely to be different in paediatric patients and
adults. They recommend that the same basic principles be followed but that the
doses be adjusted according to standard dosing principles for paediatric patients.
available for patients who are at risk for endocarditis and undergoing an
operation. The American Heart Association recently released a new guideline,
which has been endorsed by the Infectious Diseases Society of America and the
Pediatric Infectious Diseases Society (264). Endocarditis prophylaxis is not
recommended for patients undergoing surgical procedures, including endoscopy,
except for those with prosthetic valves or previous infectious endocarditis, cardiac
transplant recipients who have cardiac valvulopathy or the following examples of
congenital heart disease: unrepaired cyanotic congenital heart disease (including
patients with palliative shunts and conduits), congenital heart defects completely
repaired with prosthetic materials only during the first 6 months after the
procedure, and repaired congenital heart disease with residual defects at or
adjacent to the site of a prosthetic patch or prosthesis. The guidelines state that
no published data demonstrate a conclusive link between procedures of the
gastrointestinal or genitourinary tract and the development of infectious
92
endocarditis. Moreover, no studies exist to demonstrate that the administration
of antimicrobial prophylaxis prevents infectious endocarditis in association with
procedures performed on the gastrointestinal or genitourinary tract. For
patients with the conditions listed above who have an established
gastrointestinal or genitourinary tract infection, or for those who receive
antibiotic therapy to prevent wound infection or sepsis associated with a
gastrointestinal or genitourinary tract procedure, it may be reasonable that the
antibiotic regimen include an agent active against enterococci, such as penicillin,
ampicillin, piperacillin, or vancomycin; however, no published studies
demonstrate that such therapy would prevent enterococcal infectious
endocarditis. Amoxicillin or ampicillin is the preferred agent for enterococcal
prophylaxis for these patients. Vancomycin may be administered to patients who
do not tolerate ampicillin. If infection is caused by a known or suspected strain of
resistant Enterococcus, consultation with an infectious diseases expert is
recommended. For patients with the conditions listed above who undergo a
surgical procedure that involves infected skin, skin structure, or musculoskeletal
tissue, it is reasonable that the therapeutic regimen administered for treatment
of the infection contain an agent active against staphylococci and -hemolytic
streptococci, such as an antistaphylococcal penicillin or a cephalosporin.
Vancomycin or clindamycin may be administered to patients unable to tolerate a
-lactam or who are known or suspected to have an infection caused by a
methicillin-resistant strain of staphylococcus. Prophylaxis at the time of
cardiac surgery should be directed primarily against staphylococci and should be
of short duration. The choice of an antibiotic should be influenced by the
antibiotic susceptibility patterns at each hospital.
Minimizing contamination in the operating room
In addition to the risks that the patient, the operation and the team bring
the procedure, the environment of the operating room can also pose a risk
patients. Effective, appropriate planning and forethought in the construction
an operating room minimize such risks. Regular maintenance and cleaning
surgical suites are essential.
to
to
of
of
the use of water, detergent and wiping. As surfaces are considered non-critical
according to Spauldings classification system (265), keeping them clean should
be enough for safety. Use of disinfectants, either in a cleaning solution or
vaporized into the air, has not proven to make a difference in the rates of surgical
site infections and can pose risks to health-care workers (266).
Surgical attire: The use of masks that cover the mouth and nose, hair-coverings
such as caps, sterile surgical robes and impermeable sterile gloves is standard for
surgical teams. Some correspond to basic principles of aseptic technique and
their use is based on laboratory or microbiological studies or rationale, but
scientific evidence of their impact in preventing surgical site infections is not
available or has been disputed.
The use of masks to cover the mouth and nose is standard practice. The
purpose is to prevent contamination of the patients tissues with microorganisms
from the upper respiratory tract of the surgical team and also to prevent
93
exposure of the mouth and nose of operating room staff from splashes of blood or
other fluids from patients during a procedure. Use of masks significantly reduces
contamination of the surgical site (267,268), but the association between mask
use and surgical infections is less clear. Tunevall (269) randomly assigned 115
weeks of wearing masks or no mask during 3967 surgical operations in the period
19841985 and reported 184 surgical site infections (4.6%). When the
randomization of weeks was assessed, no differences between groups were
observed in terms of age, type of surgery, elective or not elective or clean or not
clean, and no difference in rates was documented whether masks were used or
not. Few studies have investigated whether the type of mask affects the rate of
infections, and no clear conclusions can be drawn because of low power due to the
small numbers of persons studied (270). There is evidence that the use of masks
protects from splashes of blood or other fluids from patients during surgery, but
its role in preventing the transmission of microorganisms is not clear (271273).
Sterile robes are used to prevent bacteria on the skin of surgeons from coming
into contact with the patients tissues and also to prevent blood and fluids from
patients from coming into contact with the skin of the surgical team. Some
fabrics are less permeable than others to fluids, moisture or bacteria. The use of
different fabrics did not make a difference in contamination in experimental
studies that did not involve actual surgery (274). No difference in the rates of
surgical site infections by S. epidermidis, S. aureus or other agents was observed
in randomized controlled trials of patients undergoing cardiac surgery by
surgeons wearing surgical attire made of disposable materials or reusable cotton
fabric (275277).
The use of sterile gloves for surgery is standard practice; however, 815% of
surgical gloves are torn or punctured during procedures (278280). No difference
in surgical site infections rates was observed when gloves were damaged or not
during surgery, and the use of two pairs of gloves (double gloving) did not
decrease the rates (281,282). When double gloving was used, the outer glove had
more perforations that the inner glove, and the hands of the surgical team were
less contaminated with blood or other body fluids. In a study of cerebrospinal
fluid shunt surgery, the use of double gloves was associated with a 50% reduction
in infections of the shunt as compared with use of single gloves (283).
The use of shoecovers for transit in the operating room or during surgery is a
frequent practice, although the relation between contamination of the floor of the
operating room and the rate of surgical site infections has not been established.
In a systematic review of studies published between 1950 and 2003, it was found
that the dispersion of microorganisms from the floor to the air was low and that
there was no association between the dispersion and contamination of the
surgical wound or the rate of surgical site infections (284).
Guaranteeing the sterility of surgical instruments: sterility indicators
Sterilization is the process by which an item is purged of all microorganisms
and spores. The use of sterile materials for surgery is considered standard
practice internationally. Microorganisms have different degrees of resistance to
sterilization methods depending on their type, capacity to form spores, sensitivity
to heat, chemicals and disinfectants, and the composition and thickness of the
bacterial cell wall or viral envelope. Microbial agents can be organized by their
resistance to sterilization procedures: medium-sized viruses tend to be the least
resistant to destruction, while bacterial spores tend to be the most resistant. Any
94
process that kills bacterial spores is considered to be able to eliminate all other
infectious agents, and elimination of bacterial spores is a satisfactory indicator
that sterilization has been achieved. Processes that kill M. tuberculosis but
neither bacterial spores nor prions are considered to achieve high-level
disinfection. (The destruction of prions requires special procedures and is not
described in this document.)
In the classification system of Spaulding et al. (265), devices that enter
normally sterile tissue, body cavities or the vascular system should be sterile.
Articles that come into contact with intact mucous membranes and that do not
ordinarily penetrate sterile tissue are classified as semicritical and should
receive at least high-level disinfection. Although the categories of disinfection
may be oversimplified in this system, it is currently the most useful means of
categorizing instrument decontamination.
Achieving sterility, particularly for reusable surgical instruments, requires a
sequence of cleaning and mechanical removal of gross contamination, inspection
and assembly, packaging, sterilization, storage, transport and delivery to the
operating room, and certification of the sterilization process. Cleaning is the
mechanical or chemical removal of any residual matter, organic or inorganic,
from an item with water, detergents and mechanical means. Cleaning decreases
the microbial load but does not destroy microorganisms. It can be achieved
manually or with automatic equipment. Residual organic matter interferes with
the efficacy of sterilization and disinfection by preventing contact of the
microbicidal agent with the surface of the instrument or prolonging the time of
exposure required to achieve destruction of microorganisms (285287). Because
of the significant reduction in microbial load due to cleaning, it has also been
called decontamination, especially when chemical agents are used. Inspection
consists of direct visualization of cleaned instruments, usually through a
magnifying glass, to detect residual matter (including oils or lubricants) that can
interfere with sterilization. Packaging of instruments and tray assembly must
allow the sterilizing agent to reach every item and effectively kill all
microorganisms. For successful tray packaging, the tray must not be overloaded.
The packaging should also allow handling of the tray after sterilization without
contaminating the items on it. Each sterilizing agent and method has its own
requirements for tray packaging to ensure successful sterilization (288). The
packaging system should be permeable to the sterilizing agent but resistant to
traction and manipulation.
Sterilization is the exposure of instruments, devices and other materials to a
sterilizing agent. All remaining microorganisms and spores should be eliminated
by use of this agent. A wide variety of methods is available for sterilization, and
Table II.6.10 lists the advantages and limitations of those most frequently used.
The choice of method should be based on the characteristics of the instruments
and devices, the need for proper cleaning and packaging, the time required for
exposure and sterilization, the temperature and pressure achieved, the humidity
and its potential to damage devices or items, the existence of a vacuum and
circulation of the agent within the sterilization chamber (288). These relations
are shown for the most frequent methods of sterilization in Table II.6.11.
95
Advantages
Limitations
Heat (steam
sterilization)
Short exposure
Effective for prions
Not toxic for humans or the environment
Easy certification
Low cost
Widely available
Easy to operate
Not corrosive
Deep penetration
Not toxic for humans or the environment
Easy to operate
Widely available
Long exposure
Not compatible with thermolabile items
Hard to certify
High cost
Efficacy against prions not known
Ethylene oxide
Long exposure
Not effective for prions
Toxic for humans and the environment
Hydrogen
peroxide plasma
Liquid peracetic
acid in automatic
equipment
Short exposure
Easy to operate
Not toxic for the environment
Formaldehyde
96
Temperature (C)
Pressure (atm)
15 min
121
1.5
10 min
126
2.0
3 min
134
2.9
Saturated steam
Dry heat
60 min
170
120 min
160
150 min
150
180 min
140
Overnight
121
Ethylene oxide
5h
35
2.5 h
55
Storage, transport and delivery are the processes by which the instruments
and devices are maintained until their use in the operating room. Means of
preserving the integrity and impermeability of the packaging by keeping the
sterilized materials in appropriate storage (ideally in closed, dust-free shelves
and in a dry environment) must be available.
Certification is the method by which sterilization is ascertained and
confirmed. It requires a number of procedures to verify that the process has been
successful. The physical parameters of sterilization, such as temperature,
pressure and length of exposure to the sterilizing agent, must be measured for
every sterilization cycle and load. For automatic equipment, this is frequently
measured and documented by the equipment itself. Manual equipment should be
operated by trained personnel, and calibrated thermometers, barometers, clocks
and load sensors should be used. Biological indicators contain a known load of
the most resistant microorganism killed by the sterilizing method. Spores of
Geobacillus stearothermophilus for saturated hot steam, hydrogen peroxide
plasma and formaldehyde and Bacillus subtilis var niger for dry heat and
ethylene oxide are usually used. After the process has finished, the viability of
the microorganisms is assessed. If there is no microbial activity, the process is
considered successful. The frequency of use of biological indicators has not been
standardized; however, it should be used on every load of implantable materials,
at least once a week for other materials, and always after sterilizing equipment
has been repaired. The results of these biological indicators may be available
within hours or days, depending on the type of indicator, but rarely immediately
or by visual inspection by the operating team at the time of surgery. Chemical
indicators must be used routinely to monitor the performance of the equipment
and sterilization. Existing chemical indicators are made of thermochromic ink
which changes colour when exposed to the sterilizing agent. Most sterilization
97
indicators turn from beige to black once sterilization is finished. Different types
of indicators react to different processes and serve different purposes:
Recommendations
Highly recommended:
98
Hair should not be removed unless it will interfere with the operation. If
hair is removed, it should be clipped less than 2 hours before the
operation. Shaving is not recommended as it increases the risk for
surgical site infection.
The operating team should cover their hair and wear sterile gowns and
sterile gloves during the operation.
Recommended:
Surgical drapes that are effective when wet should be used as part of the
sterile barrier.
Sterile dressing should be maintained over the surgical wound for 2448
hours.
99
Suggested:
References
1.
2.
3.
4.
5.
Khuri SF, et al. Risk adjustment of the postoperative mortality rate for the
comparative assessment of the quality of surgical care: results of the National
Veterans Affairs Surgical Risk Study. Journal of the American College of Surgeons,
1997;185:31527.
6.
Vincent C, et al. Systems approaches to surgical quality and safety: from concept to
measurement. Annals of Surgery, 2004;239:47582.
7.
8.
Burke JP. Infection controla problem for patient safety. New England Journal of
Medicine, 2003;348:6516.
Smyth ET, Emmerson AM. Surgical site infection surveillance. Journal of Hospital
Infection, 2000;45:17384.
9.
Horan TC, et al. Nosocomial infections in surgical patients in the United States,
January 1986June 1992. National Nosocomial Infections Surveillance (NNIS)
System. Infection Control and Hospital Epidemiology, 1993;14:7380.
10.
11.
Jodra VM, et al. Results of the Spanish national nosocomial infection surveillance
network (VICONOS) for surgery patients from January 1997 through December
2003. American Journal of Infection Control, 2006;34:13441.
12.
Leaper DJ, et al. Surgical site infectiona European perspective of incidence and
economic burden. International Wound Journal, 2004;1:24773.
100
13.
Astagneau P, et al. Morbidity and mortality associated with surgical site infections:
results from the 19971999 INCISO surveillance. Journal of Hospital Infection,
2001;48:26774.
14.
15.
Kirkland KB, et al. The impact of surgical-site infections in the 1990s: attributable
mortality, excess length of hospitalization, and extra costs. Infection Control and
Hospital Epidemiology, 1999;20:72530.
16.
Jenney AW, et al. Cost of surgical site infections following coronary artery bypass
surgery. Australia and New Zealand Journal of Surgery, 2001;71:6624.
17.
18.
19.
20.
Gaynes RP, et al. Surgical site infection (SSI) rates in the United States, 1992
1998: the National Nosocomial Infections Surveillance System basic SSI risk index.
Clinical Infectious Diseases, 2001;33(Suppl 2):S6977.
21.
22.
Olson MM, Lee JT Jr. Continuous, 10-year wound infection surveillance. Results,
advantages, and unanswered questions. Archives of Surgery, 1990;125:794803.
23.
24.
25.
26.
Kable AK, Gibberd RW, Spigelman AD. Adverse events in surgical patients in
Australia. International Journal of Quality in Health Care, 2002;14:26976.
27.
Campos ML, Cipriano ZM, Freitas PF. Suitability of the NNIS index for estimating
surgical-site infection risk at a small university hospital in Brazil. Infection Control
and Hospital Epidemiology, 2001;22:26872.
28.
29.
30.
101
31.
32.
33.
34.
35.
36.
37.
38.
Mangram AJ, et al. Guideline for prevention of surgical site infection, 1999.
Hospital Infection Control Practices Advisory Committee. Infection Control and
Hospital Epidemiology, 1999;20:25080.
39.
Dellinger EP. Surgical infections and choice of antibiotics. In: Sabiston DC Jr,
Lyerly HK, eds. Textbook of surgery. The biological basis of modern surgical
practice. Philadelphia, W.B. Saunders, 1997:26479.
40.
Bergamini TM, et al. The natural history of bacterial biofilm graft infection.
41.
42.
Velasco E, et al. Risk factors for infectious complications after abdominal surgery
for malignant disease. American Journal of Infection Control, 1996;24:16.
43.
44.
45.
46.
47.
48.
Lee JT. Surgical wound infections: surveillance for quality improvement. In: Fry
DE, ed. Surgical infections. Boston, Little, Brown, 1994:14559.
49.
102
50.
51.
52.
53.
Haley RW. The scientific basis for using surveillance and risk factor data to reduce
nosocomial infection rates. Journal of Hospital Infection, 1995;30(Suppl):314.
54.
Reilly JS. The effect of surveillance on surgical wound infection rates. Journal of
55.
56.
Haley RW, et al. The efficacy of infection surveillance and control programs in
preventing nosocomial infections in US hospitals. American Journal of
Epidemiology, 1985;121:182205.
57.
58.
Reilly JS, Baird D, Hill R. The importance of definitions and methods in surgical
wound infection audit. Journal of Hospital Infection, 2001;47:646.
59.
60.
Starling CE, Couto BR, Pinheiro SM. Applying the Centers for Disease Control and
Preventio. n and National Nosocomial Surveillance system methods in Brazilian
hospitals. American Journal of Infection Control, 1997;25:30311.
61.
Horan TC, et al. CDC definitions of nosocomial surgical site infections, 1992: a
modification of CDC definitions of surgical wound infections. American Journal of
Infection Control, 1992;20: 2714.
62.
63.
Wilson AP, et al. A scoring method (ASEPSIS) for postoperative wound infections
for use in clinical trials of antibiotic prophylaxis. Lancet, 1986;i:3113.
64.
Wilson AP, et al. The use of the wound scoring method 'ASEPSIS' in postoperative
wound surveillance. Journal of Hospital Infection, 1990;16:297309.
65.
Bruce J, et al. The measurement and monitoring of surgical adverse events. Health
66.
Haley RW, et al. Identifying patients at high risk of surgical wound infection. A
simple multivariate index of patient susceptibility and wound contamination.
American Journal of Epidemiology, 1985;121:20615.
67.
Geubbels EL, et al. Improved risk adjustment for comparison of surgical site
infection rates. Infection Control and Hospital Epidemiology, 2006, 27:13309.
68.
103
69.
Narong MN, et al. Surgical site infections in patients undergoing major operations
in a university hospital: using standardized infection ratio as a benchmarking tool.
American Journal of Infection Control, 2003;31:2749.
70.
Jodra VM, et al. Standardized infection ratios for three general surgery procedures:
a comparison between Spanish hospitals and US centers participating in the
National Nosocomial Infections Surveillance System. Infection Control and
Hospital Epidemiology, 2003;24:7448.
71.
Gaynes RP. Surveillance of nosocomial infections. In: Bennett JV, Brachman PS,
eds. Hospital infections. Philadelphia, Lippincott-Raven, 1998:6584.
72.
73.
74.
75.
Ehrenkranz NJ, Shultz JM, Richter EL. Recorded criteria as a 'gold standard' for
sensitivity and specificity estimates of surveillance of nosocomial infection: a novel
method to measure job performance. Infection Control and Hospital Epidemiology,
1995;16:697702.
76.
77.
Weigelt JA, Dryer D, Haley RW. The necessity and efficiency of wound surveillance
after discharge. Archives of Surgery, 1992;127:7782.
78.
Taylor EW, et al. Telephone call contact for post-discharge surveillance of surgical
site infections. A pilot, methodological study. Journal of Hospital Infection,
2003;55:813.
79.
80.
Oliveira AC, Carvalho DV. Postdischarge surveillance: the impact on surgical site
infection incidence in a Brazilian university hospital. American Journal of Infection
Control, 2004;32:35861.
81.
82.
Petherick ES, et al. Methods for identifying surgical wound infection after
discharge from hospital: a systematic review. BMC Infectious Diseases, 2006;6:170.
83.
Stuesse DC, Robinson JH, Durzinsky DS. A late sternal wound infection caused by
hematogenous spread of bacteria. Chest, 1995;108:17423.
84.
Perl TM, Golub JE. New approaches to reduce Staphylococcus aureus nosocomial
infection rates: treating S. aureus nasal carriage. Annals of Pharmacotherapy,
1998;32:S716.
85.
Kluytmans JA, et al. Nasal carriage of Staphylococcus aureus as a major risk factor
for wound infections after cardiac surgery. Journal of Infectious Disease,
1995;171:2169.
104
86.
87.
88.
89.
Slaughter MS, et al. A fifteen-year wound surveillance study after coronary artery
bypass. Annals of Thoracic Surgery, 1993;56:10638.
90.
91.
92.
He GW, et al. Risk factors for operative mortality and sternal wound infection in
bilateral internal mammary artery grafting. Journal of Thoracic and
Cardiovascular Surgery, 1994;107:196202.
93.
Lindhout AH, Wouters CW, Noyez L. Influence of obesity on in-hospital and early
mortality and morbidity after myocardial revascularization. European Journal of
Cardiothoracic Surgery, 2004;26:53541.
94.
Kaye KS, et al. The effect of increasing age on the risk of surgical site infection.
95.
Emori TG, et al. Nosocomial infections in elderly patients in the United States,
19861990. National Nosocomial Infections Surveillance System. American Journal
of Medicine, 1991;91:289S293S.
96.
97.
Vamvakas EC, Carven JH, Hibberd PL. Blood transfusion and infection after
colorectal cancer surgery. Transfusion, 1996;36:10008.
98.
Jensen LS, et al. Long-term survival after colorectal surgery associated with buffycoat-poor and leucocyte-depleted blood transfusion: a follow-up study. Lancet,
2005;365:6812.
99.
outcome
after
Agarwal N, et al. Blood transfusion increases the risk of infection after trauma.
100. Tartter PI, et al. Randomized trial comparing packed red cell blood transfusion
with and without leukocyte depletion for gastrointestinal surgery. American
Journal of Surgery, 1998;176:4626.
101. Rotstein C, et al. Determinants of clean surgical wound infections for breast
procedures at an oncology center. Infection Control and Hospital Epidemiology,
1992;13:20714.
102. Safdar N, Maki DG. The commonality of risk factors for nosocomial colonization
and infection with antimicrobial-resistant Staphylococcus aureus, enterococcus,
Gram-negative bacilli, Clostridium difficile, and Candida. Annals of Internal
Medicine, 2002;136:83444.
103. Lee JT. Operative complications and quality improvement. American Journal of
Surgery, 1996;171:5457.
104. Manian FA, Meyer L. Surgical-site infection rates in patients who undergo elective
surgery on the same day as their hospital admission. Infection Control and Hospital
Epidemiology, 1998;19:1722.
105
105. Kjonniksen I, et al. Preoperative hair removala systematic literature review.
AORN Journal, 2002;75:92838, 940.
106. Joanna Briggs Institute. The impact of preoperative hair removal on surgical site
infection. Best Practice, 2003; 7:16.
107. Paulson DS. Efficacy evaluation of a 4% chlorhexidine gluconate as a full-body
shower wash. American Journal of Infection Control, 1993;21:2059.
108. Seal LA, Paul-Cheadle D. A systems approach to preoperative surgical patient skin
preparation. American Journal of Infection Control, 2004;32:5762.
109. Hardin WD, Nichols RL. Handwashing and patient skin preparation. In: Malangoni
MA, ed. Critical issues in operating room management. Philadelphia, LippincottRaven, 1997:133149.
110. Association of Operating Room Nurses. Recommended practices for skin
preparation of patients. AORN Journal, 1996;64:8136.
111. Larson EL. APIC guideline for handwashing and hand antisepsis in health care
settings. American Journal of Infection Control, 1995;23:25169.
112. Lynch W, et al. Costeffectiveness analysis of the use of chlorhexidine detergent in
preoperative whole-body disinfection in wound infection prophylaxis. Journal of
Hospital Infection, 1992;21:17991.
113. Edwards PS, Lipp A, Holmes A. Preoperative skin antiseptics for preventing
surgical wound infections after clean surgery. Cochrane Database Systematic
Review, 2004:CD003949.
114. Gruendemann BJ, Mangum SS. Infection prevention in surgical settings.
Philadelphia, Saunders, 2001.
115. Hardin WD, Nichols RL. Aseptic technique in the operating room. In: Fry DE, ed.
Surgical infections. Boston, Little, Brown, 1995:109118.
116. Bennett SN, et al. Postoperative infections traced to contamination of an
intravenous anesthetic, propofol. New England Journal of Medicine, 1995;333:147
54.
117. Roy M. Modern approaches to preventing surgical site infections. In: Wenzel RP, ed.
Prevention and control of nosocomial infections, 4th ed. Baltimore, Williams &
Wilkins, 2003:36984.
118. Zacharias A, Habib RH. Delayed primary closure of deep sternal wound infections.
Texas Heart Institute Journal, 1996;23:2116.
119. Smilanich RP, Bonnet I, Kirkpatrick JR. Contaminated wounds: the effect of initial
management on outcome. American Surgeon, 1995;61:42730.
120. Baxter H. Management of surgical wounds. Nursing Times, 2003;99:668.
121. Fletcher J. Understanding
2005;101:534.
wound
dressings:
alginates.
Nursing
Times,
122. Zerr KJ, et al. Glucose control lowers the risk of wound infection in diabetics after
open heart operations. Annals of Thoracic Surgery, 1997;63:35661.
123. Pomposelli JJ, et al. Early postoperative glucose control predicts nosocomial
infection rate in diabetic patients. Journal of Parenteral and Enteral Nutrition,
1998;22:7781.
124. Latham R, et al. The association of diabetes and glucose control with surgical-site
infections among cardiothoracic surgery patients. Infection Control and Hospital
Epidemiology, 2001;22:60712.
125. Dellinger EP. Preventing surgical-site infections: the importance of timing and
glucose control. Infection Control and Hospital Epidemiology, 2001;22:6046.
106
126. Levetan CS, et al. Unrecognized diabetes among hospitalized patients. Diabetes
Care, 1998;21:2469.
127. Furnary AP, et al. Continuous intravenous insulin infusion reduces the incidence of
deep sternal wound infection in diabetic patients after cardiac surgical procedures.
Annals of Thoracic Surgery, 1999;67:35262.
128. Furnary AP, et al. Continuous insulin infusion reduces mortality in patients with
diabetes undergoing coronary artery bypass grafting. Journal of Thoracic and
Cardiovascular Surgery, 2003;125:100721.
129. van den Berghe G, et al. Intensive insulin therapy in the surgical intensive care
unit. New England Journal of Medicine, 2001;345:135967.
130. Garber AJ, et al. American College of Endocrinology position statement on
inpatient diabetes and metabolic control. Endocrine Practice, 2004;10(Suppl 2):49.
131. Hunt TK, et al. The effect of differing ambient oxygen tensions on wound infection.
Annals of Surgery, 1975;181:359.
132. Hohn DC, et al. Effect of O2 tension on microbicidal function of leukocytes in
wounds and in vitro. Surgery Forum, 1976;27:1820.
133. Knighton DR, Halliday B, Hunt TK. Oxygen as an antibiotic. The effect of inspired
oxygen on infection. Archives of Surgery, 1984;119:199204.
134. Knighton DR, Halliday B, Hunt TK. Oxygen as an antibiotic. A comparison of the
effects of inspired oxygen concentration and antibiotic administration on in vivo
bacterial clearance. Archives of Surgery, 1986;121:1915.
135. Knighton DR, et al. Oxygen as an antibiotic. The effect of inspired oxygen on
bacterial clearance. Archives of Surgery, 1990;125:97100.
136. Hopf, HW, et al. Wound tissue oxygen tension predicts the risk of wound infection
in surgical patients. Archives of Surgery, 1997;132:9971005.
137. Rabkin JM, Hunt TK. Local heat increases blood flow and oxygen tension in
wounds. Archives of Surgery, 1987;122:2215.
138. Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the
incidence of surgical-wound infection and shorten hospitalization. Study of Wound
Infection and Temperature Group. New England Journal of Medicine,
1996;334:120915.
139. Melling AC, et al. Effects of preoperative warming on the incidence of wound
infection after clean surgery: a randomised controlled trial. Lancet, 2001;358:876
80.
140. Frank SM, et al. Perioperative maintenance of normothermia reduces the incidence
of morbid cardiac events. A randomized clinical trial. Journal of the American
Medical Association, 1997;277:112734.
141. Greif R, et al. Supplemental perioperative oxygen to reduce the incidence of
surgical-wound infection. Outcomes Research Group. New England Journal of
Medicine, 2000;342:1617.
142. Pryor KO, et al. Surgical site infection and the routine use of perioperative
hyperoxia in a general surgical population: a randomized controlled trial. Journal of
the American Medical Association, 2004;291:7987.
143. Belda FJ, et al. Supplemental perioperative oxygen and the risk of surgical wound
infection: a randomized controlled trial. Journal of the American Medical
Association, 2005;294:203542.
144. Dellinger EP. Increasing inspired oxygen to decrease surgical site infection: time to
shift the quality improvement research paradigm. Journal of the American Medical
Association, 2005;294:20912.
107
145. Dellinger EP. Roles of temperature and oxygenation in prevention of surgical site
infection. Surgical Infections (Larchmont), 2006;7(Suppl 3):s2732.
146. Widmer AF, Frei R. Decontamination, disinfection, sterilization. In: Murray PR, et
al., eds. Manual of clinical microbiology. Washington DC, ASM Press, 2007:138
164.
147. Garibaldi RA, et al. The impact of preoperative skin disinfection on preventing
intraoperative wound contamination. Infection Control and Hospital Epidemiology,
1988;9:10913.
148. Tentative final monograph for health-care antiseptic drug products. Federal
Register, 1994;59: 3140152.
149. von Eiff C, et al. Nasal carriage as a source of Staphylococcus aureus bacteremia.
Study Group. New England Journal of Medicine, 2001;344:116.
150. Moen MD, Noone MB, Kirson I. Povidoneiodine spray technique versus traditional
scrub-paint technique for preoperative abdominal wall preparation. American
Journal of Obstetrics and Gynecology, 2002;187:14347.
151. Edmiston CE Jr, et al. Comparative of a new and innovative 2% chlorhexidine
gluconate-impregnated cloth with 4% chlorhexidine gluconate as topical antiseptic
for preparation of the skin prior to surgery. American Journal of Infection Control,
2007;35:8996.
152. Rotter ML, et al. A comparison of the effects of preoperative whole-body bathing
with detergent alone and with detergent containing chlorhexidine gluconate on the
frequency of wound infections after clean surgery. The European Working Party on
Control of Hospital Infections. Journal of Hospital Infection, 1988;11:31020.
153. Lowbury EJ, Lilly HA, Bull JP. Methods for disinfection of hands and operation
sites. British Medical Journal, 1964;2:5316.
154. Larson EL. Alcohols. In: Block SS, ed. Disinfection, sterilization and preservation.
Philadelphia, Lea & Febiger, 1991:191203.
155. Rotter MA. Alcohols for antisepsis of hands and skin. In: Ascenzi, JP, ed. Handbook
of disinfectants and antiseptics. New York, Marcel Dekker, 1966:177234.
156. Saurina G, Landman D, Quale JM. Activity of disinfectants against vancomycinresistant Enterococcus faecium. Infection Control and Hospital Epidemiology,
1997;18:3457.
157. Rutala WA. APIC guideline for selection and use of disinfectants. 1994, 1995, and
1996 APIC Guidelines Committee. Association for Professionals in Infection Control
and Epidemiology, Inc. American Journal of Infection Control, 1996;24:31342.
158. Klein M, DeForest A. The inactivation of viruses by germicides. Chemical
Specialists Manufacturing Association Proceedings, 1963;49:1168.
159. Mbithi JN, Springthorpe VS, Sattar SA. Chemical disinfection of hepatitis A virus
on environmental surfaces. Applied Environmental Microbiology, 1990;56:36014.
160. Bond WW, et al. Inactivation of hepatitis B virus by intermediate-to-high-level
disinfectant chemicals. Journal of Clinical Microbiology, 1983;18:5358.
161. Kobayashi H, et al. Susceptibility of hepatitis B virus to disinfectants or heat.
Journal of Clinical Microbiology, 1984. 20(2): p. 2146.
162. Martin LS, McDougal JS, Loskoski SL. Disinfection and inactivation of the human
T lymphotropic virus type III/lymphadenopathy-associated virus. Journal of
Infectious Diseases, 1985;152:4003.
163. van Bueren, J, Larkin DP, Simpson RA. Inactivation of human immunodeficiency
virus type 1 by alcohols. Journal of Hospital Infection, 1994;28:13748.
108
164. Kurtz JB, Lee TW, Parsons AJ. The action of alcohols on rotavirus, astrovirus and
enterovirus. Journal of Hospital Infection, 1980;1:3215.
165. Ansari SA, et al. In vivo protocol for testing efficacy of hand-washing agents against
viruses and bacteria: experiments with rotavirus and Escherichia coli. Applied
Environmental Microbiology, 1989;55:31138.
166. Turner P, Saeed B, Kelsey MC. Dermal absorption of isopropyl alcohol from a
commercial hand rub: implications for its use in hand decontamination. Journal of
Hospital Infection, 2004;56:28790.
167. Brown TL, et al. Can alcohol-based hand-rub solutions cause you to lose your
driver's license? Comparative cutaneous absorption of various alcohols.
Antimicrobial Agents and Chemotherapy, 2007;51:11078.
168. World Health Organization. WHO guidelines on hand hygene in health care
(advanced draft). Geneva, 2006.
169. Denton GE. Chlorhexidine. In: Block SS, ed. Disinfection, sterilization and
preservation. Philadelphia, Lea & Febiger, 1991:27489.
170. Ranganathan NS. Chlorhexidine. In: Ascenzi JP, ed. Handbook of disinfectants and
antiseptics. New York, Marcel Dekker, 1996:23564.
171. Maki DG, et al. Prevention of central venous catheter-related bloodstream infection
by use of an antiseptic-impregnated catheter. A randomized, controlled trial.
Annals of Internal Medicine, 1997;127:25766.
172. Larson EL, et al. Alcohol for surgical scrubbing? Infection Control and Hospital
Epidemiology, 1990;11:13943.
173. Dennis DT, et al. Tularemia as a biological weapon: medical and public health
management. Journal of the American Medical Association, 2001;285:276373.
174. Oie S, Kamiya A. Microbial contamination of antiseptics and disinfectants.
American Journal of Infection Control, 1996;24:38995.
175. Stickler DJ, Thomas B. Antiseptic and antibiotic resistance in Gram-negative
bacteria causing urinary tract infection. Journal of Clinical Pathology,
1980;33:28896.
176. Mayer S, et al. Distribution of the antiseptic resistance genes qacA, qacB and qacC
in 497 methicillin-resistant and -susceptible European isolates of Staphylococcus
aureus. Journal of Antimicrobial Chemotherapy, 2001;47:8967.
177. Mitchell BA, Brown MH, Skurray RA. QacA multidrug efflux pump from
Staphylococcus aureus: comparative analysis of resistance to diamidines,
biguanidines, and guanylhydrazones. Antimicrobial Agents and Chemotherapy,
1998;42:4757.
178. Yong D, Parker FC, Foran SM. Severe allergic reactions and intra-urethral
chlorhexidine gluconate. Medical Journal of Australia, 1995;162:2578.
179. Evans RJ. Acute anaphylaxis due to topical chlorhexidine acetate. British Medical
Journal, 1992;304:686.
180. Tabor E, Bostwick DC, Evans CC. Corneal damage due to eye contact with
chlorhexidine gluconate. Journal of the American Medical Association,
1989;261:5578.
181. Bryant WP, Zimmerman D. Iodine-induced hyperthyroidism in a newborn.
Pediatrics, 1995;95:4346.
182. Gottardi W. Iodine and iodine compounds. In: Block SS, ed. Disinfection,
sterilization and preservation. Philadelphia, Lea & Febiger, 1991:15266.
109
183. Berkelman RL, Holland BW, Anderson RL. Increased bactericidal activity of dilute
preparations of povidoneiodine solutions. Journal of Clinical Microbiology,
1982;15:6359.
184. Berkelman RL, et al. Pseudobacteremia attributed to contamination of povidone
iodine with Pseudomonas cepacia. Annals of Internal Medicine, 1981;95:326.
185. Craven DE, et al. Pseudobacteremia caused by povidoneiodine solution
contaminated with Pseudomonas cepacia. New England Journal of Medicine,
1981;305:6213.
186. Anderson RL, et al. Prolonged survival of Pseudomonas cepacia in commercially
Applied
Environmental
Microbiology,
manufactured
povidoneiodine.
1990;56:3598600.
187. Isenberg SJ, Apt L, Wood M. A controlled trial of povidoneiodine as prophylaxis
against ophthalmia neonatorum. New England Journal of Medicine, 1995;332:562
6.
188. Arata T, Murakami T, Hirai Y. Evaluation of povidoneiodine alcoholic solution for
operative site disinfection. Postgraduate Medical Journal, 1993;69(Suppl 3):S936.
189. Waran KD, Munsick
1995;345:1506.
RA.
Anaphylaxis
from
povidoneiodine.
Lancet,
190. Jones RD, et al. Triclosan: a review of effectiveness and safety in health care
settings. American Journal of Infection Control, 2000;28:18496.
191. Suller MT, Russell AD. Triclosan and antibiotic resistance in Staphylococcus
aureus. Journal of Antimicrobial Chemotherapy, 2000;46:118.
192. Aiello AE, Larson E. Antibacterial cleaning and hygiene products as an emerging
risk factor for antibiotic resistance in the community. Lancet Infectious Disease,
2003;3:5016.
193. Chuanchuen R, et al. Cross-resistance between triclosan and antibiotics in
Pseudomonas aeruginosa is mediated by multidrug efflux pumps: exposure of a
susceptible mutant strain to triclosan selects nfxB mutants overexpressing MexCDOprJ. Antimicrobial Agents and Chemotherapy, 2001;45:42832.
194. Russell AD. Whither
2004;53:6935.
triclosan?
195. Ghannoum MA, et al. Antimycotic effects of octenidine and pirtenidine. Journal of
Antimicrobial Chemotherapy, 1990;25:23745.
196. Sedlock DM, Bailey DM. Microbicidal activity of octenidine hydrochloride, a new
alkanediylbis(pyridine) germicidal agent. Antimicrobial Agents and Chemotherapy,
1985;28:78690.
197. Beiswanger BB, et al. The clinical effects of a mouthrinse containing 0.1%
octenidine. Journal of Dental Research, 1990;69:4547.
198. Tietz A, et al. Octenidine hydrochloride for the care of central venous catheter
insertion sites in severely immunocompromised patients. Infection Control and
Hospital Epidemiology, 2005;26:7037.
199. Dettenkofer M, et al. Skin disinfection with octenidine dihydrochloride for central
venous catheter placement and carea randomized controlled trial. In: 16th
European congress of clinical microbiology and infectious diseases, 2006. Nice:
European Society of Clinical Microbiology and Infectious Diseases, 2006.
200. Starr RV, Zurawski J, Ismail M. Preoperative vaginal preparation with povidone
iodine and the risk of postcesarean endometritis. Obstetrics and Gynecology,
2005;105:10249.
110
201. Reid VC, et al. Vaginal preparation with povidone iodine and postcesarean
infectious morbidity: a randomized controlled trial. Obstetrics and Gynecology,
2001;97:14752.
202. Bonten MJ, Krueger WA. Selective decontamination of the digestive tract:
cumulating evidence, at last? Seminars in Respiratory Critical Care Medicine,
2006;27:1822.
203. Camus C, et al. Prevention of acquired infections in intubated patients with the
combination of two decontamination regimens. Critical Care Medicine,
2005;33:30714.
204. Houston S, et al. Effectiveness of 0.12% chlorhexidine gluconate oral rinse in
reducing prevalence of nosocomial pneumonia in patients undergoing heart
surgery. American Journal of Critical Care, 2002;11:56770.
205. Segers P, et al. Prevention of nosocomial infection in cardiac surgery by
decontamination of the nasopharynx and oropharynx with chlorhexidine gluconate:
a randomized controlled trial. Journal of the American Medical Association,
2006;296:24606.
206. Mangram AJ, et al. Guideline for prevention of surgical site infection, 1999.
Centers for Disease Control and Prevention (CDC) Hospital Infection Control
Practices Advisory Committee. American Journal of Infection Control, 1999;27:97
132.
207. McKittrick LS, Wheelock FC Jr. The routine use of antibiotics in elective abdominal
surgery. Surgery, Gynecology and Obstetrics, 1954;99:3767.
208. Burke JF, Miles AA. The sequence of vascular events in early infective
inflammation. Journal of Pathology and Bacteriology, 1958;76:119.
209. Burke JF. The effective period of preventive antibiotic action in experimental
incisions and dermal lesions. Surgery, 1961;50:1618.
210. Stone HH, et al. Antibiotic prophylaxis in gastric, biliary and colonic surgery.
Annals of Surgery, 1976;184:44352.
211. Classen DC, et al. The timing of prophylactic administration of antibiotics and the
risk of surgical-wound infection. New England Journal of Medicine, 1992;326:281
6.
212. DiPiro JT, et al. Intraoperative serum and tissue activity of cefazolin and cefoxitin.
Archives of Surgery, 1985;120:82932.
213. van Kasteren M, et al. Antibiotic prophylaxis and the risk for surgical site infection
following total hip arthroplasty: timely administration is the most important factor.
Clinical Infectious Diseases, 2007; 44:921-7.
214. Dellinger EP. Prophylactic antibiotics: administration and timing before operation
are more important than administration after operation. Clinical Infectious
Diseases, 2007;44:92830.
215. Garey KW, et al. Timing of vancomycin prophylaxis for cardiac surgery patients
and the risk of surgical site infections. Journal of Antimicrobial Chemotherapy,
2006, 58:645650.
216. Agency for Healthcare Research and Quality - National Quality Measures
Clearinghouse. United States Department of Health and Human Services.
http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?doc_id=10258
(accessed 4 June 2008).
217. Dellinger E.P, et al. Quality standard for antimicrobial prophylaxis in surgical
procedures. Infectious Diseases Society of America. Clinical Infectious Diseases,
1994;18:4227.
111
218. Page CP, et al. Antimicrobial prophylaxis for surgical wounds. Guidelines for
clinical care. Archives of Surgery, 1993;128:7988.
219. Platt R, et al. Perioperative antibiotic prophylaxis and wound infection following
breast surgery. Journal of Antimicrobial Chemotherapy, 1993;31(Suppl B):438.
220. Platt R, et al. Prophylaxis against wound infection following herniorrhaphy or
breast surgery. Journal of Infectious Disease, 1992;166:55660.
221. Platt R, et al. Perioperative antibiotic prophylaxis for herniorrhaphy and breast
surgery. New England Journal of Medicine, 1990;322:15360.
222. Lewis RT, et al. Should antibiotic prophylaxis be used routinely in clean surgical
procedures: a tentative yes. Surgery, 1995;118:7427.
223. Platt R. Antibiotic prophylaxis in clean surgery: does it work? Should it be used if it
does? New Horizons, 1998;6(2 Suppl):S537.
224. Clarke JS, et al. Preoperative oral antibiotics reduce septic complications of colon
operations: results of prospective, randomized, double-blind clinical study. Annals
of Surgery, 1977;186:2519.
225. Nygaard K, Hognestad J. Infection prophylaxis with doxycycline in colorectal
surgery. A preliminary report. Scandinavian Journal of Gastroenterology,
1980;59(Suppl):379.
226. Washington JA 2nd, et al. Effect of preoperative antibiotic regimen on development
of infection after intestinal surgery: prospective, randomized, double-blind study.
Annals of Surgery, 1974;180:56772.
227. Baum ML, et al. A survey of clinical trials of antibiotic prophylaxis in colon surgery:
evidence against further use of no-treatment controls. New England Journal of
Medicine, 1981;305:7959.
228. Stone HH, et al. Prophylactic and preventive antibiotic therapy: timing, duration
and economics. Annals of Surgery, 1979;189:6919.
229. Polk HC Jr, Lopez-Mayor JF. Postoperative wound infection: a prospective study of
determinant factors and prevention. Surgery, 1969;66:97103.
230. Bernard H, Cole W. The prophylaxis of surgical infection. The effect of prophylactic
antimicrobial drugs on the incidence of infection following potentially contaminated
operations. Surgery, 1964;56:1517.
231. Pories WJ, et al. Prophylactic cefazolin in gastric bypass surgery. Surgery,
1981;90:42632.
232. Kaiser AB, et al. Antibiotic prophylaxis in vascular surgery. Annals of Surgery,
1978;188:2839.
233. Hasselgren PO, et al. Effects of prophylactic antibiotics in vascular surgery. A
prospective, randomized, double-blind study. Annals of Surgery, 1984;200:8692.
234. Fong I, Baker CB, McKee D. The value of prophylactic antibiotics in aortacoronary
bypass operations: a double-blind randomized trial. Journal of Thoracic and
Cardiovascular Surgery, 1979;78:908.
235. Austin TW, et al. Aortocoronary bypass procedures and sternotomy infections: a
study of antistaphylococcal prophylaxis. Canadian Journal of Surgery,
1980;23:4835.
236. Chodak GW, Plaut ME. Use of systemic antibiotics for prophylaxis in surgery: a
critical review. Archives of Surgery, 1977;112:32634.
237. Geraghty J, Feely M. Antibiotic prophylaxis in neurosurgery. A randomized
controlled trial. Journal of Neurosurgery, 1984;60:7246.
112
238. Shapiro M. Prophylaxis in otolaryngologic surgery and neurosurgery: a critical
review. Reviews of Infectious Diseases, 1991;10:S85868.
239. Barker FG 2nd. Efficacy of prophylactic antibiotics for craniotomy: a meta-analysis.
Neurosurgery, 1994;35:48492.
240. Barker FG 2nd. Efficacy of prophylactic antibiotic therapy in spinal surgery: a
meta-analysis. Neurosurgery, 2002;51:391401.
241. Norden CW. Antibiotic prophylaxis in orthopedic surgery. Reviews of Infectious
Diseases, 1991;10:S8426.
242. Lidwell OM, et al. Infection and sepsis after operations for total hip or knee-joint
replacement: influence of ultraclean air, prophylactic antibiotics and other factors.
Journal of Hygiene, 1984;93:50529.
243. Forse RA, et al. Antibiotic prophylaxis for surgery in morbidly obese patients.
Surgery, 1989;106:7507.
244. Goldmann DA, et al. Cephalothin prophylaxis in cardiac valve surgery. A
prospective, double-blind comparison of two-day and six-day regimens. Journal of
Thoracic and Cardiovascular Surgery, 1977;73:4709.
245. Platt R, et al. Antibiotic prophylaxis for cardiovascular surgery. Efficacy with
coronary artery bypass. Annals of Internal Medicine, 1984;101:7704.
246. Zelenitsky SA, et al. Antibiotic pharmacodynamics in surgical prophylaxis: an
association between intraoperative antibiotic concentrations and efficacy.
Antimicrobial Agents and Chemotherapy, 2002;46:302630.
247. Scher KS. Studies on the duration of antibiotic administration for surgical
prophylaxis. American Surgeon, 1997;63:5962.
248. Zanetti G, Giardina R, Platt R. Intraoperative redosing of cefazolin and risk for
surgical site infection in cardiac surgery. Emerging Infectious Diseases,
2001;7:82831.
249. Bucknell SJ, et al. Single- versus multiple-dose antibiotics prophylaxis for cardiac
surgery. Australia New Zealand Journal of Surgery, 2000;70:40911.
250. McDonald M, et al. Single- versus multiple-dose antimicrobial prophylaxis for
major surgery: a systematic review. Australia New Zealand Journal of Surgery,
1998;68:38896.
251. Kriaras
I,
et
al.
Antibiotic
prophylaxis
in
cardiac
surgery.
Journal of
252. Harbarth S, et al. Prolonged antibiotic prophylaxis after cardiovascular surgery and
its effect on surgical site infections and antimicrobial resistance. Circulation,
2000;101:291621.
253. ASHP Commission on Therapeutics. ASHP therapeutic guidelines on antimicrobial
prophylaxis for surgery. Clinical Pharmacy, 1992;11:483513.
254. Johns Hopkins. ABX
September 2007).
Guide.
http://www.hopkins-abxguide.org
(accessed
113
257. Finkelstein R, et al. Vancomycin versus cefazolin prophylaxis for cardiac surgery in
the setting of a high prevalence of methicillin-resistant staphylococcal infections.
Journal of Thoracic and Cardiovascular Surgery, 2002;123:32632.
258. Sullivan SA, et al. Administration of cefazolin prior to skin incision is superior to
cefazolin at cord clamping in preventing postcesarean infectious morbidity: a
randomized, controlled trial. American Journal of Obstetrics and Gynecology,
2007;196:455.
259. Griffiths J, et al. Surgical site infection following elective caesarian section: a case
control study of postdischarge surveillance. Journal of Obstetrics and Gynaecology
Canada, 2005;27:3404.
260. Smaill F, Hofmeyr GJ. Antibiotic prophylaxis for cesarean section. Cochrane
Database Systematic Reviews, 2002:CD000933.
261. Thigpen BD, et al. Timing of prophylactic antibiotic administration in the
uninfected laboring gravida: a randomized clinical trial. American Journal of
Obstetrics and Gynecology, 2005;19218648.
262. World Health Organization. Antibiotic therapy. In: Managing complications in
pregnancy and childbirth: a guide for midwives and doctors. Geneva, 2003.
263. American Academy of Pediatrics Committee on Infectious Diseases, Committee on
Drugs and Section on Surgery. Antimicrobial prophylaxis in pediatric surgical
patients. Pediatrics, 1984;74:4379.
264. Wilson W, et al. Prevention of infective endocarditis: guidelines from the American
Heart Association: a guideline from the American Heart Association Rheumatic
Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular
Disease in the Young, and the Council on Clinical Cardiology, Council on
Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes
Research Interdisciplinary Working Group. Circulation, 2007;116:173654.
265. Spaulding E, Cundy K, Turner F. Chemical disinfection of medical and surgical
materials. In: Lawrence C, ed. Disinfection, sterilization, and preservation.
Philadelphia, Lea & Febiger, 1977:65484.
266. Dettenkofer M, et al. Does disinfection of environmental surfaces influence
nosocomial infection rates? A systematic review. American Journal of Infection
Control, 2004;32:849.
267. Alwitry A, et al. The use of surgical facemasks during cataract surgery: is it
necessary? British Journal of Ophthalmology, 2002;86:9757.
268. McLure HA, et al. Surgical face masks and downward dispersal of bacteria.
Anaesthesia, 1998;53:6246.
269. Tunevall TG. Postoperative wound infections and surgical face masks: a controlled
study. World Journal of Surgery, 1991;15:3838.
270. Lipp A, Edwards P. Disposable surgical face masks: a systematic review. Canadian
Operating Room Nursing Journal, 2005;23:201, 245, 338.
271. Collins D, et al. Quantification of facial contamination with blood during
orthopaedic procedures. Journal of Hospital Infection, 2000;45:735.
272. Sharma JB, et al. Facial and body blood contamination in major gynecologic
surgeries. Journal of Obstetrics and Gynaecology Research, 2003;29:4025.
273. Aisien AO, Ujah IA. Risk of blood splashes to masks and goggles during cesarean
section. Medical Science Monitor, 2006;12:CR947.
274. Friberg B, Friberg S, and Burman LG. Correlation between surface and air counts
of particles carrying aerobic bacteria in operating rooms with turbulent ventilation:
an experimental study. Journal of Hospital Infection, 1999;42:618.
114
275. Bellchambers J, et al. A prospective study of wound infection in coronary artery
surgery. European Journal of Cardiothoracic Surgery, 1999;15:4550.
276. Tammelin A, Hambraeus A, Stahle E. Routes and sources of Staphylococcus aureus
transmitted to the surgical wound during cardiothoracic surgery: possibility of
preventing wound contamination by use of special scrub suits. Infection Control
and Hospital Epidemiology, 2001;22:33846.
277. Tammelin A, Hambraeus A, Stahle E. Source and route of methicillin-resistant
Staphylococcus epidermidis transmitted to the surgical wound during cardiothoracic surgery. Possibility of preventing wound contamination by use of special
scrub suits. Journal of Hospital Infection, 2001;47:26676.
278. Al-Habdan I, Sadat-Ali M. Glove perforation in pediatric orthopedic practice.
Journal of Pediatric Orthopedics, 2003;23:7913.
279. Alrawi S, et al. Glove reinforcement: an alternative to double gloving. Infection
Control and Hospital Epidemiology, 2001;22:5267.
280. Dodds RD, et al. Surgical glove perforation. British Journal of Surgery,
1988;75:9668.
281. Tanner J, Parkinson H. Double gloving to reduce surgical cross-infection. Cochrane
Database of Systematic Reviews, 2006;3:CD003087.
282. Dodds RD, et al. Self protection in surgery: the use of double gloves. British Journal
of Surgery, 1990;77:21920.
283. Tulipan N, Cleves MA. Effect of an intraoperative double-gloving strategy on the
incidence of cerebrospinal fluid shunt infection. Journal of Neurosurgery,
2006;104(1 Suppl):58.
284. Medeiros Lutz Santos A, Aparecida Lacerda R, Uchikawa Graziano K. [Evidence for
lack of efficicacy of shoe covers and dedicated shoes in the control and prevention of
infection in surgical settings: systematic review of the literature.] Revista LatinoAmericana Enfermagem, 2005;13:8692.
285. Sykes G. The phenomenon of bacterial survival. Journal of Applied Bacteriology,
1963;62:916.
286. Silva e Souza AC, Pereira MS, Rodrigues MA. [Disinfection of medical and surgical
equipment: efficacy of chemical disinfectants and water and soap.] Revista LatinoAmericana Enfermagem, 1998;6:95105.
287. de la Pena J, et al. Cleaning and disinfection of gastrointestinal endoscopes.
Comparative analysis of two disinfectants. Revista Espaola de Enfermedades
Digestivas, 1999;91:48996.
288. Perkins J. Sterilizer controls, indicators and tests. In: Principles and methods in
health sciences, 2nd ed. Springfield, Illinois, Charles C. Thomas, 1983.
115
Objective 7: The team will prevent inadvertent retention of instruments or
sponges in surgical wounds.
Inadvertently leaving a sponge, needle or instrument in a patient at the end
of an operation is a rare but persistent, serious surgical error. Because of its
rarity, it is difficult to estimate the frequency with which it occurs; the best
estimates range from 1 in 5000 to 1 in 19 000 inpatient operations, but the
likelihood has been estimated to be as high as 1 in 1000 (14). Retained sponges
and instruments tend to result in serious sequelae, including infection, reoperation for removal, bowel perforation, fistula or obstruction and even death. A
number of factors contribute to this error, but the evidence points to three clear
risk factors: emergency surgery, high body mass index and an unplanned change
in the operation (3). Other risk factors that may contribute are high-volume blood
loss and the involvement of multiple surgical teams, although these factors did
not reach statistical significance in the study. Sponges and instruments can be
retained during any surgical procedure on any body cavity, regardless of the
magnitude or complexity.
A team process for manually counting all instruments and sponges at the
start and conclusion of a surgical operation is standard practice for numerous
nursing organizations. The Association for Perioperative Practice (formerly the
National Association of Theatre Nurses, United Kingdom), the Association of
peri-Operative Registered Nurses (United States), the Australian College of
Operating Room Nurses, Operating Room Nurses Association of Canada and the
South African Theatre Nurse have all established recommendations and
standards for sponge and instrument counts to reduce the incidence of retained
sponges and instruments during surgery (59). Measures such as incorporating
radio-opaque material in sponges make it possible to find those that have been
retained on intraoperative radiographs if there is a miscount. The standards
have several common elements, including standardization of the counting
procedure and systematic tracking and accounting of items on the sterile field
and in the wound.
Manual counting methods are not fool-proof, as they are subject to human
error. Newer techniques, which include automated counting and tracking of
sponges, appear to increase the accuracy of counting and the detection of
inadvertently retained sponges. New methods include use of bar-coded sponges
and sponges with radiofrequency identification tags. A randomized trial of a barcoded sponge system showed a threefold increase in detection of miscounted or
misplaces sponges (10). The cost of such systems, however, can range from US$
13 per case for bar-coded sponges to US$ 75 per case for radiofrequency-tagged
sponges.
General criteria for counting
As part of the overall tracking of items in the operating room, each facility
should have a policy for surgical counts that specifies when they should be
performed and by whom, what items should be counted and how counts
(including incorrect counts) should be documented. A specific procedure for
counting should be established to ensure that the protocols are standardized and
familiar to operating room personnel. Specific low-risk procedures (e.g.
cystoscopy, cataract surgery) can be exempted from the counting protocols, but
they should exceptions rather than a general rule. Most established protocols
include all or nearly all the recommendations listed below.
116
A full count of sponges, sharps, miscellaneous items (small item such as
tapes, clips and drill bits) and instruments should be performed when the
peritoneal, retroperitoneal, pelvic and thoracic cavities are entered. Counts
should also be done for any procedure in which these items could be retained in
the patient, and must be conducted at least at the beginning and end of every
eligible case. A tally of all counted items should be maintained throughout the
operation. Any items designated as part of the counting protocol that are added
during the procedure should be counted and recorded upon entry onto the sterile
field. Ideally, preprinted count sheets for sponges, sharps and instruments
should be used and included in the patient's record whenever possible. Other
recording strategies, such as using whiteboards to track counts, are also
acceptable, in accordance with hospital protocol.
Counting should be performed by two persons, such as the scrub and
circulating nurses, or with an automated device, when available. When there is
no second nurse or surgical technician, the count should be done by the surgeon
and the circulating nurse. If a count is interrupted, it should be started again
from the beginning. Ideally, the same two persons should perform all counts.
When there is a change in personnel, a protocol for transfer of information and
responsibility should be clearly delineated in hospital policy.
Items should be viewed and audibly counted concurrently. All items should be
separated completely during a count. Counts should be performed in a consistent
sequence, for example, sponges, sharps, miscellaneous items and instruments at
the surgical site and immediate area, then the instrument stand, the back table
and discarded items.
The team member responsible for the count should be aware of the location of
all counted items throughout the operation. Items included in the count should
not be removed from the operating room until the final count is completed and
the counts are reconciled. The results of counts should be announced audibly to
the surgeon, who should give verbal acknowledgement. In the event that an
incision is re-opened after the final count, the closure count should be repeated.
When a count cannot be performed, an X-ray should be taken before the patient
leaves the operating room, if the patient's status permits, or as soon as possible
thereafter.
117
equivalent) in established multiples. Soiled dissecting sponges (e.g. peanuts)
should be kept in their original container or a small basin until counted.
Sharps count (e.g. suture and hypodermic needles, blades, safety pins): Sharps
should be counted before the start of the procedure, before closure of a cavity
within a cavity, before wound closure (at first layer of closure) and at skin
closure. Suture needles should be counted according to the marked number on
the package. The number of suture needles in a package should be verified by the
counters when the package is opened. Needles should be contained in a needle
counter or container, loaded onto a needle driver or sealed with their package.
Needles should not be left free on a table.
Instrument count: Instruments should be counted before the start of the
procedure and before wound closure (at first layer of closure). Instrument sets
should be standardized (i.e. same type and same number of instruments in each
set) and a tray list used for each count. Instruments with component parts should
be counted singly (not as a whole unit), with all component parts listed (e.g. one
retractor scaffold, three retractor blades, three screws). Instruments should be
inspected for completeness. All parts of a broken or disassembled instrument
should be accounted for. If an instrument falls to the floor or is passed off the
sterile field, it should be kept within the operating room until the final count is
completed. No instrument should be removed from the operating room until the
end of the procedure.
Documentation of counts
Counts should be recorded on a count sheet or nursing record. The names and
positions of the personnel performing the counts should be recorded on the count
sheet and in the patient's record. The results of surgical counts should be
recorded as correct or incorrect. Instruments and sponges intentionally left with
the patient should be documented on the count sheet and in the patient's record.
Any action taken in the event of a count discrepancy or incorrect count should be
documented in the patient's record. Reasons for not conducting a count in cases
that normally demand a count should be documented in the patient's record.
Count discrepancies
Every health-care facility should have a policy for the procedure to follow in
case of a count discrepancy. When counts are discrepant, the operating-room
personnel must perform a recount, and, if they are unable to reconcile the counts,
they should immediately notify the surgeon and the operating room supervisor
and conduct a search for the missing item, including the patient, floor, garbage
and linen. If the counts remain unreconciled, the team should ask for a
radiograph to be takenwhen availableand document the results on the count
sheet and in the patient's record. When a count ought to be performed but is not,
the surgeon and operating room supervisor should be notified, a radiograph
taken at the completion of the procedure and an accurate record of why the count
was not undertaken and the results of the radiographs noted.
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Methodical wound exploration before closure
Alternative methods for tracking and accounting for surgical sponges,
instruments, sharps and other items should be considered as they become
available and validated. Manual counts nevertheless remain the most readily
available means of preventing retained sponges and instruments. Counting
clearly prevents retained items from being left in a patients body cavity but is
fraught with error. In a study of retained surgical instruments, Gawande et al.
(3) noted that in 88% of cases of retained sponges and instruments in which
counts were performed, the final count was erroneously believed to be correct.
This implies a dual error: leaving an item in the patient, and a counterbalancing
miscount that results in a false correct count.
Preventing the unintentional retention of surgical objects in a surgical wound
requires clear communication among the team members. All operating-room
personnel have a role to play in avoiding this error. While the task of keeping
track of sponges and instruments placed within a surgical wound is commonly
delegated to the nursing or scrub staff, the surgeon can decrease the likelihood of
leaving a sponge or instrument behind by carefully and methodically examining
the wound before closure in every case. This practice has been advocated by the
American College of Surgeons as an essential component of preventing retained
sponges and instruments (11). This type of evaluation addresses
counterbalancing errors in counting that might lead to a false correct count. It is
cost-free and provides an added safety check to minimize the risk of leaving a
sponge or instrument behind.
Recommendations
Highly recommended:
Counts should be recorded, with the names and positions of the personnel
performing the counts and a clear statement of whether the final tally was
correct. The results of this tally should be clearly communicated to the
surgeon.
Suggested:
119
References
1. Bani-Hani KE, Gharaibeh KA, Yaghan RJ. Retained surgical sponges (gossypiboma).
Asian Journal of Surgery, 2005, 28:10915.
2. Egorova NN, et al. Managing the prevention of retained surgical instruments: what is
the value of counting? Annals of Surgery, 2008, 247:138.
3. Gawande AA, et al. Risk factors for retained instruments and sponges after surgery.
New England Journal of Medicine, 2003, 348:22935.
4. Gonzalez-Ojeda A, et al. Retained foreign bodies following intra-abdominal surgery.
Hepatogastroenterology, 1999;46:80812.
5. National Association of Theatre Nurses. Swab, instrument and needles count. In:
NATN standards and recommendations for safe perioperative practice. Harrogate,
2005:2337.
6. Association of peri-Operative Registered Nurses. Recommended practices for sponge,
sharp, and instrument counts. In: Standards, recommended practices and guidelines.
Denver, Colorado, AORN, Inc, 2007:493502.
7. Australian College of Operating Room Nurses and Association of peri-Operative
Registered Nurses. Counting of accountable items used during surgery. In: Standards
for perioperative nurses. O'Halloran Hill, South Australia, ACORN, 2006:112.
8. Operating Room Nurses Association of Canada. Surgical counts. In: Recommended
standards, guidelines, and position statements for perioperative nursing practice.
Canadian Standards Assocation, Mississauga, 2007.
9. South African Theatre Nurse. Swab, instrument and needle counts. In: Guidelines for
basic theatre procedures. Panorama, South Africa, 2007.
10. Greenberg CC, et al. Bar-coding surgical sponges to improve safety: a randomized
controlled trial. Annals of Surgery, 2008;247:6126.
11. American College of Surgeons. Statement on the prevention of retained foreign bodies
after surgery. http://www.facs.org/fellows_info/statements/st-51.html (accessed 5
February 2008).
120
121
Objective 8: The team will secure and accurately identify all surgical specimens.
While there are considerable data on processing and diagnostic errors
associated with surgical specimens, there is scant evidence about the incidence
and nature of errors due to inadequate or wrong labelling, missing or inadequate
information and lost specimens, all of which can potentially hinder patient care
and safety (1,2). An analysis of medico-legal claims for errors in surgical
pathology revealed that 8% were due to operational errors (2). Such incidents
are accompanied by delays in treatment, repeated procedures and surgery on the
wrong body part. Such incidents occur in all specialties and all types of tissue (3).
In a study of identification errors in laboratory specimens from 417 United
States institutions, nearly 50% were due to labelling errors (4). Transfusion
medicine has led the way in highlighting the importance of specimen labelling,
but errors in laboratory tests can also result in patient harm. One in 18 labelling
errors results in an adverse event, and, in the United States, it has been
estimated that close to 160 000 adverse events occur annually because of
mislabelling. Errors in labelling laboratory specimens occur because of
mismatches between the specimen and the requisition and unlabelled or
mislabelled specimens (5). Patient identification on specimens and requisition
forms is critical in any attempt to prevent laboratory errors. The Joint
Commission made accurate patient identification one of their laboratory patient
safety goals (6). Improved identification is crucial to preventing errors in
laboratory specimen labelling. Rechecking wrist identification bands can
decrease specimen labelling error rates and blood grouping errors (79).
Mislabelling of surgical pathology specimens can have more severe
consequences (10) than other laboratory errors that occur before specimen
analysis (7). A recent study by Makary et al. (3) showed that errors occur in 3.7
per 1000 specimens from operating rooms and involve the absence of accurate
labelling, omission of details regarding tissue site and the absence of patient
name. Several simple steps can be taken to minimize the risk of mislabelling.
First, the patient from whom each surgical specimen is taken should be identified
with at least two identifiers (e.g. name, date of birth, hospital number, address).
Second, the nurse should review the specimen details with the surgeon by
reading aloud the name of the patient listed and the name of the specimen,
including the site of origin and any orienting markings. When required by a
facility, the surgeon should complete a requisition form labelled with the same
identifiers as the specimen container. This requisition form should be crosschecked against the specimen by the nurse and surgeon together before it is sent
to the pathology department and should include the suspected clinical diagnosis
and the site (and side or level when applicable) from which the sample was
taken.
Recommendations
Highly recommended:
The team should confirm that all surgical specimens are correctly labelled
with the identity of the patient, the specimen name and location (site and
side) from which the specimen was obtained, by having one team member
read the specimen label aloud and another verbally confirming agreement.
122
References
1. Cooper K. Errors and error rates in surgical pathology: an Association of Directors of
Anatomic and Surgical Pathology survey. Archives of Pathology and Laboratory
Medicine, 2006;130:6079.
2. Troxel DB. Error in surgical pathology. American Journal of Surgical Pathology,
2004;28:10925.
3. Makary MA, et al. Surgical specimen identification errors: a new measure of quality
in surgical care. Surgery, 2007;141:4505.
4. Valenstein PN, Raab SS, Walsh MK. Identification errors involving clinical
laboratories: a College of American Pathologists Q-Probes study of patient and
specimen identification errors at 120 institutions. Archives of Pathology and
Laboratory Medicine, 2006;130:1106113.
5. Wagar EA, et al. Patient safety in the clinical laboratory: a longitudinal analysis of
specimen identification errors. Archives of Pathology and Laboratory Medicine, 2006.
130(11): p. 16621668.
6. Joint
Commission.
2007
national
patient
safety
goals.
http://www.jointcommission.org/patientsafety/nationalpatientsafetygoals (accessed 3
May 2007)
7. Howanitz PJ. Errors in laboratory medicine: practical lessons to improve patient
safety. Archives of Pathology and Laboratory Medicine, 2005;129:125261.
8. Howanitz PJ, Renner SW, Walsh MK. Continuous wristband monitoring over 2 years
decreases identification errors: a College of American Pathologists Q-Tracks study.
Archives of Pathology and Laboratory Medicine, 2002;126:80915.
9. Lumadue JA, Boyd JS, Ness PM. Adherence to a strict specimen-labeling policy
decreases the incidence of erroneous blood grouping of blood bank specimens.
Transfusion, 1997;37:116972.
10. Chassin MR, Becher EC. The wrong patient. Annals of Internal Medicine,
2002;136:82633.
123
Objective 9: The team will effectively communicate and exchange critical
information for the safe conduct of the operation.
The pursuit of safety is about making the system as robust as practicable
in the face of human and operational hazards wrote James Reason, one of the
pioneers of human error evaluation (1). Failures within a system, particularly
catastrophic ones, rarely happen as a result of a single unsafe act. Rather, they
are the culmination of multiple errors involving the task, team, situation and
organization, which build up to a calamitous event. The factors responsible for
these errors fall into seven broad categories: high workload; inadequate
knowledge, ability or experience; poor human factor interface design; inadequate
supervision or instruction; stressful environment; mental fatigue or boredom; and
rapid change.
Human rather than technical failures are the greatest threat to complex
systems. While human fallibility can be moderated, it cannot be eliminated.
Complex systems such as aviation and the nuclear industry have come to accept
the inevitability of human error (2). Such systems build in mechanisms to reduce
and manage errors, in the form of technological innovations such as simulations,
team training initiatives and simple reminders such as checklists.
Surgery is similarlyand perhaps even morecomplex, because of the
number of people involved, the acuteness of the patients condition, the amount of
information required, the urgency with which it must be processed, and the
technical demands on health-care professionals. Other factors in the system, such
as heavy workload, stress, fatigue, hierarchical structures and organizational
factors, often contribute to an error-prone environment (3,4). As in other complex
systems, communication among team members is essential for safe team
functioning. Omission, misinterpretation and conflict arising from poor
communication can result in adverse patient outcomes (57). Yet, unlike other
complex systems, persons involved in current surgical practice do not regard
human error as inevitable and have attempted only intermittently to build
systematic safety features into care.
There is growing evidence that communication failures among team members
are a common cause of medical errors and adverse events. The Joint Commission
reported that in the United States communication was a root cause of nearly 70%
of the thousands of adverse events reported to the organization between 1995
and 2005 (8). Furthermore, operating teams seem to recognize that
communication breakdowns can be a fundamental barrier to safe, effective care.
In one survey, two thirds of nurses and physicians cited better communications
in a team as the most important element in improving safety and efficiency in the
operating room (9).
Team culture and its effects on safety
A central element in safe surgery and the avoidance of unnecessary mishaps
appears to be the empowerment of team members to raise and act on concerns
about the safety of the patient or the operation. Interdisciplinary discussions to
ensure adequate planning and preparation for each surgical case are an essential
starting-point for effective team communication. The creation of an environment
that permits and fosters such discussions depends, however, on a constructive
team culture.
124
Three elements contribute to a teams culture: the structure of the team, the
perception of team roles and team members attitudes to safety issues. The team
structure is the teams composition, hierarchy, and the distribution and
coordination of work among individuals and professional groups. Operating
teams include the surgeons, anaesthesia professionals, nurses and other
technicians involved in the perioperative care of surgical patients. These
disciplines frequently function in what has been termed silos: they work
together, ostensibly forming a team, but the worlds of surgery, nursing and
anaesthesia can be very different, and in some environments they barely
interact. This professional identification and resulting segregation translate into
practice patterns that function independently (and often in parallel) in the same
physical space, with some overlapping duties, and that foster distinct
expectations and values (10). These patterns constrain a teams ability to
function effectively, particularly in complex, unpredictable work processes.
Furthermore, operating teams tend to be strongly hierarchical, and team
members are reluctant to communicate among hierarchical levels (11). While
simple linear tasks, such as checking equipment, can be performed well in a
hierarchical structure, complex tasks such as shared decision-making may be
inhibited and require a less hierarchical, more collaborative approach to
teamwork (12).
Team members can make different assumptions about how work is to be
distributed and coordinated within the team. For example, surgeons and
anaesthesiologists might have conflicting perceptions about who is responsible
for ensuring timely administration of antibiotic prophylaxis (13). Ambiguity in
team structure can be a product of interprofessional disagreements about how
tasks should be distributed and valued (14). Formalization and standardization
are not common in operating room teamwork, due to medicines strongly held
value of professional autonomy and its craftsman mindset, factors that promote
individualism as opposed to cooperation and can act as barriers to achieving safer
health care (15).
The attitudes of team members often reflect and reproduce the organizational
culture in which they work. Surveys have shown that they often have discrepant
attitudes about their ability to work as a team and about communication among
disciplines. Qualitative evaluations of intensive care unit teams showed that, in
contrast to physicians, nurses reported that it was difficult to speak up,
disagreements were not appropriately resolved, and more input into decisionmaking was needed (11). In the operating room, the differences in attitudes
between surgeons and the other team members can be substantial (16). It is
important to understand these attitudes: research in aviation has shown that
positive attitudes about teamwork are associated with error-reducing behaviour
(17). A similar association has been found between attitude shifts and improved
patient outcomes in intensive care units (18,19). Unlike personality, attitudes
are amenable to change (11).
A culture of teamwork and communication can lead to better patient
outcomes. A steep hierarchy exists in most operating rooms that affects the
extent to which the teams function effectively (12). Professional affiliation,
perception of roles, gender differences and seniority can all foster isolation and
segregation, limiting interaction and interdisciplinary questioning. Evaluations
of other highly reliable organizations, such as aviation, reveal that strategies
such as the use of checklists, standard operating protocols and communication
interventions such as team briefings and debriefings aid in task completion and
125
foster a culture of open communication. Such interventions standardize processes
and act as reminders, so that team members need not rely solely on memory
recall. In complex systems in which many people and advanced techniques are
involved, appropriate procedures are needed to manage and prevent adverse
events. Without such systems, problems are almost inevitable. Health care
comprises an enormous diversity of tasks and goals, whereas aviation, nuclear
power generation and railways are relatively homogeneous. Furthermore, the
vulnerability of patients increases their liability to serious damage by unsafe
acts.
Patterns of communication breakdown
Observational research in United States academic health centres revealed
patterns of communication breakdown among operating teams. Breakdowns can
occur during the preoperative, intraoperative and postoperative phases of
surgical care and can result in death, disability or prolonged hospital stay for
patients (20). A study of communication failures in the operating room found that
they occur in approximately 30% of team exchanges (21). Fully one third of these
breakdowns jeopardize patient safety by increasing cognitive load, interrupting
routines and increasing tension. The ability to coordinate activities in the
operating room varies widely among hospitals and among disciplines. Both
observational data and the experience of operating room personnel indicate lack
of discussion and planning, including the absence of formal systematic checks,
before skin incision (16,22).
While there is some evidence of poor communication patterns in the
intraoperative phase, only a few studies have addressed failures in handover of
the patient postoperatively (21,23,24). Inadequate handover, when patients are
transferred from one care site to another and during shift changes, has been
found to be a safety risk (25,26). The absence of structured information flow
among team members and ambiguity about responsibilities hinder effective
communication throughout the perioperative period (20). Failure to communicate
intraoperative events resulted in inappropriate monitoring of patients
postoperatively, absence of enhanced vigilance for specific, predictable
postoperative complications, and medication errors such as lapses or delays in
administering antibiotics and anticoagulation regimens. The frequency of such
omissions remains unknown. In its sentinel event investigations, the Joint
Commission has made improvement of handovers among team members through
standardization one of its core goals in patient safety (27).
Reducing communication breakdown during surgery
Pre-procedural briefings are considered critical in other highly complex fields
in order to improve safety. They act by engendering shared mental models among
team members (28). Briefings facilitate the transfer of critical information and
create an atmosphere of openness in which team members feel empowered to
contribute. The Joint Commission recommends use of a time out or surgical
pause to allow the team to confirm the patient, the procedure and the site of
operation before the incision (29). This is now a mandatory requirement in all
operating rooms in the United States and has laid the foundation for trials of
preoperative team briefings, in which additional safety checks are merged into
the time out. Recent studies suggest that using the time just before skin incision
126
to review the names and roles of all team members, key checks, the operating
plan, familiarity with the procedure and issues that might be encountered during
the case is of significant value (30). In studies in single institutions, use of
preoperative operating room briefings was associated with an improved safety
culture, a reduction in wrong-site or wrong-procedure surgery, early reporting of
equipment issues, reduced operation costs and improvements in the use of
prophylactic medication (antibiotics or thromboembolism prophylaxis) in the
perioperative period (3134).
Preoperative checks vary in content according to the centre. They usually
include checks to confirm use of infection prophylaxis and the availability of
critical equipment and resources. In an observational study of 10 surgical
procedures, about 15 resources were added per procedure after the beginning of
the operation (24). Equipment problems are more likely to disrupt workflow,
delay case progression and lead to deterioration in the dynamics among team
members than compromise patient safety. In a survey of operating room team
members, respondents felt that nearly 10% of errors in operating rooms were
related to equipment problems (35). The American College of Surgeons Closed
Claims Study showed that the errors in 5% of claims were equipment-related
(36). Equipment-related issues not only delay case progression but cause
surgeons to adjust their technique and the procedure to work around equipment
problems (24). Although this phenomenon has not been studied in detail, such
adaptation could result in technical errors. The Kaiser-Permanente organization
(United States) found that preoperative briefings that included a check on
whether the equipment required or expected for the procedure was available
resulted in reduced equipment problems and an increase in staff morale (33).
Training for and implementing the briefing required minimal resources.
Preoperative briefings or checks can also include discussion of modifications
to routine operating plans, specific concerns about the patient and the
availability of necessary imaging for the operation. The Australian Incident
Monitoring Study found that nearly 25% of clinical incidents resulted from poor
preoperative information, assessment and preparation (37). Imaging can provide
independent confirmation of the site for operation, when it is available (38). In
cases of bilaterality, multiple body parts (e.g. fingers) or multiple levels (e.g.
spinal surgery), the American College of Surgeons has proposed that imaging
should be prominently displayed in the operating room (39). Images can also be
important in cases in which intraoperative decisions about the extent of surgical
resection are made. Such decisions often depend on a combination of surgical and
radiographic evaluation of size and anatomical location of the diseased area (e.g.
soft tissue and solid organ tumours).
In general, preoperative briefing sessions are a means of timely information
transfer among team members. The intensity and nature of the work in an
operating room may mean that team members will have to be prompted to use a
checklist or briefing (28). While some may see the briefings as an interruption,
most surgeons, anaesthesiologists, nurses and technicians who have participated
in this type of study reported that the benefits outweighed the inconvenience
(34,4042).
Post-procedure debriefings consist of a pause at the conclusion of an operation
to give the team an opportunity to review what was done, any critical events
during the case and the management plans for recovery. Debriefings have been
tested at various centres to see whether they improve the reliability of care (41).
127
Incorporation of safety checks into debriefings could form the basis for a safety
intervention. The combination of team briefings and debriefings significantly
improved the perceived collaboration of operating room personnel (30). Although
their effect on patient outcomes is less clear, an established recovery plan
highlights any concerns about recovery.
Use of checklists to improve safety and communication
Checklists counteract human failures of omission. Omissions are most likely
occur when there is information overload, multiple steps in a process, repeated
steps and planned departures from routine procedures. Interruptions and
distractions are also causal factors in errors of omission (43,44).
Checklists are routinely used in high-reliability organizations such as
aviation and the nuclear power industry. In aviation, their use is mandatory for
every stage of a flight, and failure to use a checklist is considered a violation of
flight protocol and a flight error (45). Checklists have been used in a number of
health-care specialties, such as intensive care and anaesthesia. Their use in
health care has met with some scepticism, for practical and cultural reasons. It
would be difficult to standardize treatment for the considerable variety of
patients, and standardization would not take into consideration differences in
clinical presentation and demographics and comorbid conditions. Resistance to
their use stems from the perception that they undermine the professional
autonomy of clinicians (45).
In order to appreciate the limitations of checklists in the clinical setting, it is
crucial to assess their value objectively. Checklist fatigue can result from the
use of multiple checklists (45), and use of checklists can actually lead to errors if
they are seen as extraneous and unimportant. If multiple checks are performed
by multiple providers, a person may declare that an item has been checked even
when it has not, thus perpetuating errors. Exhaustive checklists can slow the
process of care and may alienate the users. This may foster negative attitudes
and defeat the purpose of a checklist, which is to create a safety climate.
Even a checklist with simple items that clinicians consider routine and
clearly defined can have merit. In an attempt to reduce central venous catheter
infections, Pronovost et al. (46) instituted a checklist in over 100 intensive care
units in the State of Michigan, United States. Simple checks ensured that
providers washed their hands before the procedure; wore gloves, a gown, a hat
and a mask; properly prepared the skin at the insertion site; draped the patient
and maintained a sterile field; and evaluated the patient daily to determine
whether the catheter was needed. They found a dramatic decrease in the rate of
catheter-related infections when teams adhered to these simple measures,
providing a model for how a simple checklist can induce clinicians to adhere to
known safety measures in their daily practice.
Record-keeping
Accurate record-keeping is integral to providing high-quality care (47,48).
Although there is little experimental evidence of its value, broad experience has
established its importance for maintaining adequate communications in
professional practice (49,50). Good record-keeping is regarded as a mark of an
organized, safe practitioner. Medical records exist for the benefit of the patient
128
and for reference by future health-care providers. The General Medical Council of
the United Kingdom specifies that doctors should keep clear, accurate, legible
and contemporaneous patient records which report the relevant clinical findings,
the decisions made, the information given to patients and any drugs or other
treatment prescribed. It also states that doctors should keep colleagues well
informed when sharing the care of patients (51). As surgical care is provided by
a multidisciplinary team, often working in a variety of settings and locations, the
accuracy and clarity of written records ensures that information that affects care
is readily available to all the personnel involved. Patient records allow all team
members to reconstruct events and enable them to plan further treatment or
interventions on the basis of full information about clinical history and events.
Good record-keeping is an accepted component of surgical care and an important
means of promoting high-quality health care.
In order to improve communication, team members must communicate
before, during and after a procedure. Preparation for a complex case should
ideally begin before the day of surgery in order to ensure the preparedness of the
team for any critical event. Conscientious use of a checklist before induction of
anaesthesia, before skin incision and before the patient is removed from the
operating room can facilitate communication and focus all team members on the
critical steps that will prevent harm and improve safety.
Recommendations
Highly recommended:
Before skin incision, the surgeon should ensure that team members, in
particular nurses, anaesthesia professionals, and surgical assistants are
aware of the critical steps of the procedure to be performed, the risk for
heavy blood loss, any special equipment needed (such as instruments,
implants, intraoperative imaging, frozen section pathology) and any likely
deviation from routine practice. The nurse(s) should inform the team
members about any critical safety concerns and the lack of availability or
preparation of any special equipment. The anaesthesia professional
should inform the team about any critical safety concerns, in particular
any difficulty in preparing for resuscitation after heavy blood loss or
patient comorbidities that add risk to the anaesthesia.
Before removing the drapes at the end of the operation, the surgeon
should inform team members of any alterations that were made to the
procedure performed, any problems that may occur in the postoperative
period and essential postoperative plans (which might include antibiotics,
venous thromboembolism prophylaxis, oral intake or drain and wound
care). The anaesthesia professional should summarize the clinical
condition of the patient during the operation and any other instructions
needed to ensure a safe recovery. The nurse should notify the team of any
additional concerns recognized during the operation or for recovery.
129
References
1. Reason J. Human error: models and management. British Medical Journal,
2000;320:76870.
2. Reason J. Human error. Cambridge, Cambridge University Press, 1992.
3. Vincent C, et al. Systems approaches to surgical quality and safety: from concept to
measurement. Annals of Surgery, 2004;239:47582.
4. Helmreich RL. On error management: lessons from aviation. British Medical Journal,
2000;320:7815.
5. Leonard M, Graham S, Bonacum D. The human factor: the critical importance of
effective teamwork and communication in providing safe care. Quality and Safety in
Health Care, 2004;13(Suppl 1):i8590.
6. Frankel A, et al. Using the communication and teamwork skills (CATS) assessment
to measure health care team performance. Joint Commission Journal on Quality and
Patient Safety, 2007. 33(9): p. 54958.
130
7. Rogers, D.A. and L. Lingard, Surgeons managing conflict: a framework for
understanding the challenge. Journal of the American College of Surgeons,
2006;203:56874.
8. Joint
Commission.
Sentinel
event
statistics,
31
December
2006.
http://www.jointcommission.org/SentinelEvents/Statistics (accessed 5 May 2007).
9. Sexton JB, Thomas EJ, Helmreich RL. Error, stress, and teamwork in medicine and
aviation: cross sectional surveys. British Medical Journal, 2000;320:7459.
10. Bleakley A, et al. Improving teamwork climate in operating theatres: the shift from
multiprofessionalism to interprofessionalism. Journal of Interprofessional Care,
2006;20:46170.
11. Thomas EJ, Sexton JB, Helmreich RL. Discrepant attitudes about teamwork among
critical care nurses and physicians. Critical Care Medicine, 2003;31:9569.
12. Healey AN, Undre S, Vincent CA Defining the technical skills of teamwork in
surgery. Quality and Safety in Health Care, 2006;15:2314.
13. Tan JA, Naik VN, Lingard L. Exploring obstacles to proper timing of prophylactic
antibiotics for surgical site infections. Quality and Safety in Health Care, 2006;15:32
8.
14. Undre S, et al. Teamwork in the operating theatre: cohesion or confusion? Journal of
Evaluation in Clinical Practice, 2006;12:1829.
15. Amalberti R, et al. Five system barriers to achieving ultrasafe health care. Annals of
Internal Medicine, 2005;142:7564.
16. Makary MA, et al. Operating room teamwork among physicians and nurses:
teamwork in the eye of the beholder. Journal of the American College of Surgeons,
2006;202:74652.
17. Helmreich RL, et al. Cockpit resource management: exploring the attitude
performance linkage. Aviation, Space and Environmental Medicine, 1986;57:1198
200.
18. Shortell SM, et al. The performance of intensive care units: does good management
make a difference? Medical Care, 1994;32:50825.
19. Baggs JG, et al. The association between interdisciplinary collaboration and patient
outcomes in a medical intensive care unit. Heart and Lung: The Journal of Acute and
Critical Care, 1992;21:1824.
20. Greenberg CC, et al. Patterns of communication breakdowns resulting in injury to
surgical patients. Journal of the American College of Surgeons, 2007;204:53340.
21. Lingard L, et al. Communication failures in the operating room: an observational
classification of recurrent types and effects. Quality and Safety in Health Care,
2004;13:3304.
22. Sexton JB, et al. Teamwork in the operating room: frontline perspectives among
hospitals and operating room personnel. Anesthesiology, 2006;105:87784.
23. Guerlain S, et al. Assessing team performance in the operating room: development
and use of a 'black-box' recorder and other tools for the intraoperative environment.
Journal of the American College of Surgeons, 2005;200:2937.
24. Christian CK, et al. A prospective study of patient safety in the operating room.
Surgery, 2006;139:15973.
25. Williams RG, et al. Surgeon information transfer and communication: factors
affecting quality and efficiency of inpatient care. Annals of Surgery, 2007;245:15969.
131
26. Van Eaton EG, Horvath KD, Pellegrini CA. Professionalism and the shift mentality:
how to reconcile patient ownership with limited work hours. Archives of Surgery,
2005;140:2305.
27. Joint Commission. Improving handoff communications: meeting national patient
safety goal 2E. http://www.jcipatientsafety.org/15427/ (accessed 8 February 2008).
28. Lingard L, et al. Getting teams to talk: development and pilot implementation of a
checklist to promote interprofessional communication in the OR. Quality and Safety
in Health Care, 2005;14:3406.
29. Joint Commission. Universal protocol for preventing wrong site, wrong procedure,
wrong
person
surgery.
http://www.jointcommission.org/PatientSafety/UniversalProtocol/
(accessed
15
February 2007).
30. Makary MA, et al. Operating room briefings and wrong-site surgery. Journal of the
American College of Surgeons, 2007;204:23643.
31. Awad SS, et al. Bridging the communication gap in the operating room with medical
team training. American Journal of Surgery, 2005;190:7704.
32. Altpeter T, et al. Expanded surgical time out: a key to real-time data collection and
quality improvement. Journal of the American College of Surgeons, 2007;204:52732.
33. DeFontes J, Surbida S. Preoperative safety briefing project. Permanente Journal,
2004;8:217.
34. Makary MA, et al. Operating room briefings: working on the same page. Joint
Commission Journal on Quality and Patient Safety, 2006;32:3515.
35. Flin R, et al. Attitudes to teamwork and safety in the operating theatre. Surgeon,
2006;4:14551.
36. Griffen FD, et al. The American College of Surgeons' closed claims study: new
insights for improving care. Journal of the American College of Surgeons,
2007;204:5619.
37. Kluger MT, et al. Inadequate pre-operative evaluation and preparation: a review of
197 reports from the Australian incident monitoring study. Anaesthesia,
2000;55:11738.
38. Michaels RK, et al. Achieving the National Quality Forum's 'never events': prevention
of wrong site, wrong procedure, and wrong patient operations. Annals of Surgery,
2007;245:52632.
39. American College of Surgeons. Statement on ensuring correct patient, correct site,
and correct procedure surgery. Bulletin of the American College of Surgeons, 2002;87.
40. Makary MA, et al. Patient safety in surgery. Annals of Surgery, 2006;243:62832.
41. Makary MA, et al. Operating room debriefings. Joint Commission Journal on Quality
and Patient Safety, 2006;32:357,40710.
42. Lingard L, et al. Evaluation of a preoperative checklist and team briefing among
surgeons, nurses, and anesthesiologists to reduce failures in communication. Archives
of Surgery, 2008;143:128.
43. Reason J. Combating omission errors through task analysis and good reminders.
Quality and Safety in Health Care, 2002;11:404.
44. Catchpole KR, et al. Improving patient safety by identifying latent failures in
successful operations. Surgery, 2007;142:10210.
45. Hales BM, Pronovost PJ. The checklista tool for error management and
performance improvement. Journal of Critical Care, 2006;21:2315.
132
46. Pronovost P, et al. An intervention to decrease catheter-related bloodstream
infections in the ICU. New England Journal of Medicine, 2006;355:272532.
47. Nursing
and
Midwifery
Council.
Advice
http://www.nmc.org.uk (accessed 19 July 2007).
sheet
on
record
keeping.
48. Medical Protection Society. Keeping medical recordsa comprehensive guide for
consultants. http://www.mps.org.uk (accessed 19 July 2007).
49. World Health Organization. Integrated management for emergency and essential
surgical care. Best practice protocols for clinical procedures safety.
http://www.who.int/surgery (accessed 6 February 2007).
50. World Health Organization. Global burden of disease estimates, 2002.
http://www.who.int/healthinfo/bodgbd2002/en/index.html (accessed 20 October 2006).
51. General
Medical
Council.
Good
medical
practice.
http://www.gmcuk.org/guidance/good_medical_practice/GMC_GMP.pdf (accessed 12 December 2007).
133
Objective 10: Hospitals and public health systems will establish routine
surveillance of surgical capacity, volume and results.
Assessment of success, failure and progress in the provision and safety of
surgical care relies on information on the status of care. Practitioners, hospitals
and public health systems require information on surgical capacity, volume and
results, to the extent practicable. Success in other fields of public health, such as
the safety of childbirth, reduction of HIV transmission and the eradication of
poliomyelitis, has been shown to depend on surveillance (14). Improvement of
surgical safety and access is no different.
The absence of data on surgery in WHO metrics has probably contributed to
the failure to recognize the enormous volume of surgery that is performed
throughout the world and its contribution to avoidable disability and death (5).
These guidelines therefore list an essential set of vital statistics for surgical
surveillance at a systems level and simple patient-level measures for use by
hospitals and practitioners.
The current model for measuring health-care delivery is the Donabedian
framework (6,7). First introduced in 1966, this framework is based on three types
of metric: measures of structure, process and outcome.
health.
The strength of the Donabedian framework lies in the relations between these
measures. As illustrated in Figure 10.1, structure influences process and process
in turn influences outcome (8). A comprehensive assessment of health-care
delivery requires understanding of all three elements individually and the
relations among them.
Figure 10.1 The interaction of structure, process and outcome on health care
134
outcome and while tracking process efforts such as the use of a safety checklist
and implementation of standardized protocols for care. The goal is to assess both
access to and quality of care. Because of the significant difficulties associated
with almost any form of measurement, the programme sought to maintain
simplicity.
There are no simple measures to evaluate surgical care. In public health
programmes to reduce maternal and infant mortality, data on structure, process
and outcome are used to derive information about the quantity and quality of
maternal care. The data include fertility rates, the volume of cesarean sections,
the proportion of births assisted by a skilled birth attendant and the number of
such attendants in a country, as well as outcome measures such as maternal
mortality, infant mortality and Apgar scores. This guideline therefore outlines a
similar set of indicators for which standardized data on the volume and safety of
surgery can be collected and compared.
Feasibility and implications of measurement
In order to obtain surgical vital statistics, it is essential to have practical
indicators and a realistic mechanism for data collection. WHOs Health Metrics
Network defines the issues as follows (9):
Data sources. There are two main types of data source: those generating
135
tomography scanners) or other costly equipment. Feasible data collection tools
can help a country to manage its information system in order to make surgical
care both safe and cost-effective. The cost of efforts to collect data must translate
into health savings for the population.
improve surgery throughout the world for several reasons. Most importantly, it
will provide a global baseline evaluation of the quantity and public health
outcomes of the surgical care currently delivered. It will also establish a
foundation on which to base evaluations of interventions to improve surgical
access and safety. It will help establish health information systems specifically
for surgery and surgical diseases that can be further developed and refined over
time.
The usefulness of surgical vital statistics may extend beyond these direct
consequences. Assessing surgical care on a global basis may improve care simply
through the power of measurement and reporting. Better awareness of the
accessibility and outcomes of surgical care may cause subtle but tangible
improvements in care delivery, thus creating a positive incentive to improve
surgical results.
Negative incentives: Data collection can also have a perverse effect on health
care, giving a negative incentive to caring for the sickest patients. A countrys
desire to appear to be performing high-quality surgery at an adequate volume
may create an unintended incentive to increase the number of inappropriate
elective operations, underreport mortality, discharge sick patients early and fail
to operate on critically ill patients. It must be clear that surgical statistics are
intended to help a country to improve its health system and the delivery and
safety of surgical care, given its available resources. They are not intended or
designed for comparing the quality of care in different health systems but
represent a benchmark for progress in public health.
Case mix and risk adjustment: Any comparison must account for variations in
patient conditions and the complexity of procedures. Methods to evaluate the
differences between facilities and practitioners, even within a single institution,
must take into account the characteristics of the patients, the case mix, urgency
and hospital setting. Such complex data collection is beyond the capacity of most
countries at present. Furthermore, the public health goal of this WHO initiative
is to reduce complications and deaths from surgery, regardless of whether they
are due to patient or institutional factors. Therefore, these guidelines outline the
data required to provide basic information on surgical capacity, volume and
overall outcomes.
Current measures in surgery
countries, as less than 30% of countries have publicly available data on the
volume of surgery performed nationally, and the data are infrequently updated.
In the absence of standardized reporting, the data are based on various
136
definitions, making analysis difficult. Procedures such as percutaneous
interventions, endoscopy, radiographically guided procedures and wound
debridements are often excluded, even when performed under anaesthesia. In
addition, administrative data systems may not record multiple operations on a
single patient; billing data may miss surgical care provided outside the
established payment system; facility surveys typically omit certain types of care
facilities (such as private clinics and hospitals); and outpatient surgical
procedures are often excluded.
137
resources may be able to collect more extensive data on surgical care. Interest in
expanding data collection is expected to increase once the basic measures of
surgery are in place and apparent differences in the outcome of surgical care
emerge. Therefore, in addition to defining the basic statistics for all countries,
intermediate and advanced surgical vital statistics are described, which, when
feasible, could further increase international understanding of the effect of
surgical care on public health.
Basic surgical vital statistics: A review of current needs, capabilities and practice
was the basis for a set of surgical vital statistics. The goal is that all WHO
Member States attempt to collect this information annually and to include it in
their annual health reports. It was highly recommended that data from basic
surgical surveillance include:
These basic measures are the structural and outcome components of surgical
delivery systems. The structural metrics indicate the capacity of a country for
delivering care. The number of operating rooms, the number of operations
performed in operating rooms and the number of trained surgeons and
anaesthesia professionals are measures of the resources available for delivery of
surgical care. The day of surgery death rate and overall in-hospital death rate
provide broad indicators of surgical outcomes, much as maternal and neonatal
mortality rates do for obstetric outcomes.
The number of operating rooms in each country: Delivery of surgical services
is an important component of health systems. Knowing the operating room
density will help evaluate the availability, access and distribution of surgical
services and coverage. An operating room is defined as an enclosed room
specifically dedicated to surgical procedures and equipped to deliver monitored
anaesthesia, whether or not it is located in a hospital facility. Potential sources of
data for this measure include administrative records based on reported data by
inpatient and outpatient facilities and censuses of health facilities with possible
adjustment for underreporting (e.g. missing private facilities).
Certain procedures, such as incision and drainage of wounds, endoscopy and
dilation and curettage, may be performed in procedure rooms that are not
suitable for other types of invasive operations. Minor procedure rooms should not
be included unless they meet the definition of an operating room.
The number of surgical procedures performed in operating rooms in each
country: The number of surgical procedures performed in an operating room is
an indication of access to and use of health care, particularly surgical services. A
surgical procedure is defined as the incision, excision or manipulation of tissue
138
that requires regional or general anaesthesia or profound sedation to control
pain. Potential sources of data for this measure include hospital records and
routine health service statistics with possible adjustment for underreporting (e.g.
surgery in the private sector). If data from only a subset of operating rooms (e.g.
excluding private facilities) are reported, the number of operating rooms in the
sample should be given.
This indicator does not provide information on the reason for performing a
procedure and includes operations that might be performed without a clinical
indication, in addition to those that are medically necessary. It is therefore not
possible to determine whether a surgical procedure is performed according to
clinical need. There is no consensus about the volume of surgery that ought to be
performed in a given population, as the surgical rate changes according to the
disease burden of the population and as indications for procedures change over
time. Baseline rates of surgery can, however, help establish whether a health
system is meeting the minimum surgical needs of a population.
Many invasive procedures not typically considered to be surgery might be
listed as a surgical procedure, such as endoscopy with or without biopsy and
percutaneous vascular interventions. As these procedures may be performed in
an operating room or an alternative procedure room, their inclusion may
confound the data collection. Invasive procedures that meet the definition but are
performed in a procedure room not suitable for larger invasive operations should
not be considered in the total number of surgical procedures. If, however, they
are performed in an operating room, they should be counted. In addition, the
requirement that surgical procedures take place in an operating room does not
exclude ambulatory operations, which make up a substantial and growing
proportion of surgical care in some countries.
The numbers of trained surgeons and trained anaesthesia professionals in
each country: The availability and composition of human resources for health are
important indicators of the strength of a health system. Furthermore, as the
disease burden shifts from infectious to chronic conditions, well-trained
practitioners will be increasingly necessary for providing appropriate care. While
there is no consensus about the optimal number of surgeons or anaesthetists for
a population, specialist coverage and the quality of the provider are important for
safe and appropriate provision of surgical care. In general, a surgeon is a
physician who treats disease, injury or deformity by operative or manual
methods (40). The designation trained refers to those practitioners registered by
accepted national standards, each country defining what these standards are.
Thus, surgeons are defined as physicians who have achieved certification in one
of the surgical specialties as recognized by the accepted standards of the Member
State or the national professional organization. Anaesthesia professionals are
physicians, nurses and other practitioners who have achieved certification in the
provision of anaesthesia as recognized by the accepted standards of the Member
State or the national professional organization. Persons who perform surgery or
administer anaesthesia but are not trained, including those in training, would
not be included in this measure. Data sources for these measurements may
include facility surveys, labour force surveys and records from professional and
administrative sources.
139
Number of deaths on the day of surgery: Death on the day of surgery reflects
comorbid conditions and physiological derangements in the patient, the quality
and complexity of surgical care, the risks of anaesthesia or some combination of
these three. These events are the basis for evaluating the performance of the
health system and the state of health of the population. This measure is most
useful when converted to day-of-surgery death rate, defined as the number of
deaths on the day of surgery per 10 000 surgical procedures in a given year or
period. Potential sources of data include administrative and hospital records
based on health service statistics, with possible adjustment for underreporting
(e.g. death on the day of surgery that occurs outside the surveillance system or
which is not reported).
Although fairly rare, death on the day of surgery is an important indicator of
patient, surgeon, operation and anaesthesia characteristics. There is no
consensus about what an acceptable day-of-surgery mortality rate might be,
particularly as it often reflects a combination of factors. This metric will provide
valuable insight into the patterns of surgical deaths within a health system, from
the burden of disease in a population that prompts them to seek surgical care to
the skill, judgement and technical capacity of the surgery and anaesthetic
providers. It cannot, however, be used to compare one site, facility or country
with another without appropriate, valid, time-consuming risk adjustment.
Number of in-hospital deaths after surgery: Complications and death are not
uncommon after surgical procedures. The in-hospital death rate after surgery
provides insight into the risks associated with surgical intervention. Like the
previous measure, this is most useful when converted to a postoperative inhospital death rate, defined as the number of deaths in the hospital within 30
days of any surgical procedure per 10 000 surgical procedures performed in a
given year or period. Potential sources of data include administrative and
hospital records based on health service statistics, with possible adjustment for
underreporting (e.g. in-hospital surgical death that occurs outside the
surveillance system or which is not reported).
This measure reflects the number of patients who have undergone a surgical
procedure and die in a hospital within 30 days of their operation. Patients who
undergo surgery and are discharged but die outside a health facility would not be
counted as in-hospital surgical deaths. The number does, however, include
patients who undergo a procedure at one facility but are transferred and die in
another within 30 days of the operation. The postoperative in-hospital death rate
varies considerably with the type of procedure being performed, the type of
health facility, the health of the population and the distribution of the burden of
disease. Thus, comparisons of facilities and countries without risk adjustment
are discouraged. The measure should instead be used to guide health service
workers to improve performance and the outcomes of surgical patients.
The weaknesses of these death rate measures must be clearly understood.
Both are subject to potential misinterpretation, because they do not specify the
cause of death. The measures have a potential perverse effect insofar as they may
encourage premature discharge of patients to avoid an impending death from
occurring in the hospital. These measures are not intended to limit access to care
or to subvert the procedure by which patients are evaluated, preoperatively or
postoperatively. A surgical mortality rate, as noted above, reflects the patients
condition on arrival for surgery, the extent and complexity of the procedure and
140
the quality of care. Patients who die because of lack of timely surgical care are
not counted either, because of the difficulty of doing so, although this measure
would also indicate the quality of care. These are simple metrics that can provide
a gauge of the overall outcome of surgical care and a target for progress in public
health, but not strict measures of the quality of care.
Collection of the five surgical vital statistics is expected to build a foundation
of information about surgical care that will give it the visibility of other
important areas of public health. As the strengths and weaknesses of surgical
care are ascertained, the information should advance the knowledge of surgical
services and provide valuable information for improving safety.
Intermediate-level surgical vital statistics: For countries that can build on the
basic statistics, several intermediate-level measures will help further define the
capacity, volume and outcome of surgical services. The recommended measures
are:
141
could include general categories, such as operations on the cardiovascular
system, digestive system and nervous system. Data on the five or ten most
frequent operations performed in a country could also be collected. The number of
operations should be disaggregated into emergent or elective cases, if available
and consistently defined.
The intermediate outcome measures are the same death statistics specified as
basic statistics, that is, deaths on the day of surgery and in-hospital deaths after
surgery. The added value would be to collect these measures for the subgroups
discussed above: general categories of surgery, most frequent operations, specific
surgical cases and emergent or elective surgery. Mortality per capita and per
operation could be calculated for these subgroups, which would help identify
specific problem areas.
142
impact of surgical care on death, disability and resources, which is a vital matter
for public health planning now that the global volume of surgical procedures
exceeds that of childbirth (5).
Surgical surveillance: Basic patient measures at hospital and practitioner levels
While national data such as vital statistics allow countries to track progress
and identify problems from year to year, quality improvement in hospitals
requires more regular local feedback for clinicians on outcomes of care (42). Thus,
these guidelines define a set of basic surgical measures for use by hospitals and
practitioners in any setting worldwide.
143
infections can readily be reduced by improving care (see Objective 6).
Institutional surveillance of surgical site infection is essential for improving
surgical quality and safety.
144
0 points
1 point
2 points
3 points
Estimated blood
loss (mL)a
>1000
601-1000
101-600
100
Lowest mean
arterial pressure
(mm Hg)b,c
<40
40-54
55-69
70
>85*
76-85
66-75
56-65
4 points
55*
*Occurrence of pathologic bradyarrhythmia, including sinus arrest, atrioventricular block or dissociation, junctional
or ventricular escape rhythms, and asystole also receive 0 pts for lowest heart rate
a
The estimated blood loss used in the calculation should be the number entered in the official operation record.
This is usually computed by the anaesthetist and confirmed by the surgeon. While this method may seem
imprecise, estimates of blood loss have been shown to be accurate within orders of magnitude (53,54).
b
The heart rate and blood pressure should be obtained from the anaesthesia record, as values recorded from
the time of incision to the time of wound closure.
c
Mean arterial pressure should be used to calculate the blood pressure score. When the systolic and diastolic
blood pressures are recorded without mean arterial pressure, the lowest mean arterial pressure must be
calculated by selecting the lowest diastolic pressure and using the formula: mean arterial pressure = diastolic
pressure + (systolic pressurediastolic pressure)/3.
d
In cases in which asystole or complete heart block occurs, the score for heart rate should be 0.
Table II.10.2 Relative risks for major complications or death based on the
Surgical Apgar Score, with a score of 7 as the reference value (at a United
States academic medical center)
Surgical
Apgar Score
Total no. of
patients
No. with
complications
Complication
rate
p value
04
128
72
0.563
3.4 (2.74.2)
< 0.0001
233
93
0.399
2.4 (1.93.0)
< 0.0001
487
108
0.222
1.3 (1.11.7)
0.017
730
122
0.167
Reference
Reference
1100
114
0.104
0.6 (0.50.8)
< 0.0001
1091
55
0.010
0.3 (0.20.4)
< 0.0001
10
350
17
0.049
0.3 (0.20.5)
< 0.0001
Total
4119
581
0.141
145
Findings from international pilot sites: The Surgical Apgar Score was designed
for international use as a measure of outcome for surgical patients. It has been
validated in published findings for more than 5000 patients undergoing general
and vascular surgical procedures at two large academic medical centres in the
United States. Preliminary data showed that it also had predictive value in
urological and orthopaedic patients in these institutions (57 and personal
communication from T, Wuerz, Department of Orthopedic Surgery,
Massachusetts General Hospital, Boston, 2008). Its value was further confirmed
in eight hospitals in Canada, India, Jordan, New Zealand, the Philippines, the
United Kingdom, the United Republic of Tanzania and the United States,
participating as international pilot sites in the WHO Safe Surgery Saves Lives
programme. These hospitals are a heterogeneous group of institutions, ranging
from high- to low-income settings. Data collected at baseline included the
Surgical Apgar Score, inpatient complications and inpatient deaths up to 30 days
after surgery in 3435 consecutive adults undergoing non-cardiac surgical
procedures, including general and trauma surgery, orthopaedic surgery,
urological surgery and obstetric and gynaecological surgery. One or more inhospital complications occurred in 366 (10.7%) patients during postoperative
follow-up. Table II.10.3 shows the distribution of these patients by Surgical
Apgar Score: patients with a score of 10 had a complication rate of 3.9%, while
36.2% of those with a score less than 5 had at least one complication.
Table II.10.3 Relative risks for major complication or death based on the
Surgical Apgar Score, with a score of 7 as the reference value (at eight
international pilot sites, World Health Organization Safe Surgery Saves Lives
project data)
Surgical
Apgar Score
Total no. of
patients
No. with
complications
Adjusted
complication
rate*
p value
04
141
51
0.362
2.8 (1.84.2)
< 0.0001
348
56
0.171
1.3 (0.82.1)
0.088
672
87
0.137
1.1 (0.71.6)
0.754
720
89
0.131
Reference
Reference
809
50
0.067
0.5 (0.30.7)
< 0.0001
593
27
0.051
0.4 (0.20.6)
< 0.0001
10
152
0.039
0.3 (0.10.9)
0.004
Total
3435
366
0.107
146
to and control haemodynamic changes during the procedure. Alterations in the
heart rate and blood pressure often represent both the physiological status of the
patient and the adequacy of anaesthetic management. Blood loss is an indicator
of the complexity of an operation and the performance of the surgeon. These
components result in a Surgical Apgar Score that gives feedback to clinicians on
the relative success of their operation and the relative risks for complications or
death.
This measure has several important potential uses. Like the Apgar score in
obstetrics, the Surgical Apgar Score can give practitioners a target for care,
inciting them to ensure that patients have as high a score as possible. It also
identifies groups at high risk for complications, indicating the need for more
monitoring, vigilance and readiness to intervene. It can also identify near-miss
cases, whether or not complications actually occur. For administrators, it offers a
target for quality improvement, either to decrease the proportion of patients with
low scores or to increase the proportion with high scores. While the score does not
allow comparisons of quality between institutions because of the influence of
case-mix and variations in the condition of the patient on presentation, it can be
used in any setting, as it is derived only from routinely available intraoperative
data.
Recommendations
Highly recommended:
147
surgical site infection rate and
Surgical Apgar Score.
Recommended:
Suggested:
In Member States with the resources and capability to conduct riskadjusted evaluations, countries should adjust outcome data for case mix
and extend outcome measures to include morbidity by defining
complications and conducting independent clinical surveillance for followup and detection of complications.
References
1. World Health Organization. Millennium development goals. Geneva, 2000.
2. World Health Organization. Make every mother and child count: The World Health
Report 2005. Geneva, 2005.
3. Ronsmans C, et al. Maternal mortality: who, where, and why. Lancet, 2006,
368:1189200.
4. World Health Organization. World health statistics
www.who.org/statistics (accessed 20 October 2006).
2007.
Geneva,
2007.
5. Weiser T, et al. An estimation of the global volume of surgery. Lancet (accepted for
publication).
148
6. Donabedian A. Evaluating the quality of medical care. Milbank Memorial Fund
Quarterly, 1966, 44:166203.
7. Donabedian A. Explorations in quality assessment and monitoring. Vol I. The
definition of quality and approaches to its assessment, 1980; Vol II. The criteria and
standards of quality, 1982; Vol III. The methods and findings of quality assessment
and monitoring: an illustrated analysis. Ann Arbor, Michigan, Health Administration
Press, 1985.
8. Makary MA, et al. Patient safety in surgery. Annals of Surgery, 2006, 243:62832.
9. Health Metrics Network. Framework and standards for the development of country
health information systems. Geneva, World Health Organization, 2006.
10. Lunn JN. The history and achievements of the National Confidential Enquiry into
Perioperative Deaths. Journal of Quality in Clinical Practice, 1998, 18:2935.
11. Gray A. United Kingdom national confidential enquiry into perioperative deaths.
Minerva Anestesiologica, 2000;66:28892.
12. Hannan EL, et al. Improving the outcomes of coronary artery bypass surgery in New
York State. Journal of the American Medical Association, 1994;271:7616.
13. Wyse RK, Taylor KM. Using the STS and multinational cardiac surgical databases to
establish risk-adjusted benchmarks for clinical outcomes. Heart Surgery Forum,
2002;5:25864.
14. Tu JV, Wu K. The improving outcomes of coronary artery bypass graft surgery in
Ontario, 1981 to 1995. Canadian Medical Association Journal, 1998;159:2217.
15. Khuri SF. Safety, quality, and the National Surgical Quality Improvement Program.
American Surgeon, 2006;72:9948.
16. Khuri SF, et al. The National Veterans Administration Surgical Risk Study: risk
adjustment for the comparative assessment of the quality of surgical care. Journal of
the American College of Surgeons, 1995;180:51931.
17. Khuri SF, et al. Risk adjustment of the postoperative mortality rate for the
comparative assessment of the quality of surgical care: results of the National
Veterans Affairs Surgical Risk Study. Journal of the American College of Surgeons,
1997;185:31527.
18. Horntrich J. [Surgical quality assurance in the former Cottbus district]. Zentralblatt
fur Chirurgie, 2000;125(Suppl 2):1123.
19. Hupe K, Wenning M. [Value of current quality assurance for surgery]. Zentralblatt
fur Chirurgie, 2000;125(Suppl 2):1468.
20. Laas HD, Scheibe O. [Baden-Wurttemberg quality assurance in surgery]. Swiss
Surgery, 1995;1:359.
21. Schmidt C, et al. [Quality management in surgeryan overview of methods and
possibilities]. Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen,
2003;74:5019.
22. Troidl H. [Quality control in surgery of inguinal hernias]. Chirurg; Zeitschrift fur alle
Gebiete der operativen Medizen, 1997, 68:122534.
23. Celso B, et al. A systematic review and meta-analysis comparing outcome of severely
injured patients treated in trauma centers following the establishment of trauma
systems. Journal of Trauma, 2006;60:3718.
24. Jurkovich GJ, Mock C. Systematic review of trauma system effectiveness based on
registry comparisons. Journal of Trauma, 1999 Sep;47(3 Suppl):S4655.
25. Mock C, et al. Overview of the Essential Trauma Care Project. World Journal of
Surgery, 2006;30:91929.
149
26. Mock C. Improving prehospital trauma care in rural areas of low-income countries.
Journal of Trauma, 2003;54:11978.
27. Mock CN, et al. The development of continuing education for trauma care in an
African nation. Injury, 2005;36:72532.
28. Mock C, et al. Strengthening the prevention and care of injuries worldwide. Lancet,
2004;363:21729.
29. National Cancer Insititue. Surveillance, Epidemiology, and End Results (SEER)
database. http://seer.cancer.gov (accessed 5 May 2008).
30. Begg CB, et al. Impact of hospital volume on operative mortality for major cancer
surgery. Journal of the American Medical Association, 1998;280:174751.
31. Schrag D, et al. Influence of hospital procedure volume on outcomes following surgery
for colon cancer. Journal of the American Medical Association, 2000;284:302835.
32. Bach PB, et al. The influence of hospital volume on survival after resection for lung
cancer. New England Journal of Medicine, 2001;345:1818.
33. Hershman D, et al. Timing of adjuvant chemotherapy initiation after surgery for
stage III colon cancer. Cancer, 2006;107:25818.
34. Govindarajan A, et al. Population-based assessment of the surgical management of
locally advanced colorectal cancer. Journal of the National Cancer Institute,
2006;98:147481.
35. Baxter NN, et al Lymph node evaluation in colorectal cancer patients: a populationbased study. Journal of the National Cancer Institute, 2005;97:21925.
36. Cummings LC, Payes JD, Cooper GS. Survival after hepatic resection in metastatic
colorectal cancer: a population-based study. Cancer, 2007;109:71826.
37. Malthaner R, Fenlon D. Preoperative chemotherapy for resectable thoracic
esophageal cancer. Cochrane Database of Systematic Reviews (Online),
2003:CD001556.
38. Dal Poz MR, et al. Counting health workers: definitions, data, methods and global
results. Geneva, World Health Organization, 2006.
39. World Health Organization. Working together for health: The World Health Report
2006. Geneva, 2006.
40. Webster's New World Medical Dictionary, 3rd Ed. New York, Wiley, 2008.
41. American College of Surgeons. National Surgical Quality Improvement Program
(NSQIP), 2008 www.acsnsqip.org/ (accessed 15 May 2008).
42. Berwick DM. The science of improvement. Journal of the American Medical
Association, 2008;299:11824.
43. McLaws ML, Murphy C, Keogh G. The validity of surgical wound infection as a
clinical indicator in Australia. Australian and New Zealand Journal of Surgery,
1997;67:6758.
44. Burke JP. Infection controla problem for patient safety. New England Journal of
Medicine, 2003;348:6516.
45. Smyth ET, Emmerson AM. Surgical site infection surveillance. Journal of Hospital
Infection, 2000;45:17384.
46. Health Protection Agency. Surgical Site Infection Surveillance Service (SSISS).
http://www.hpa.org.uk/webw/HPAweb&Page&HPAwebAutoListName/Page/11919421
50156?p=1191942150156 (accessed 13 May 2008).
150
47. Wilson J, et al. Rates of surgical site infection after hip replacement as a hospital
performance indicator: analysis of data from the English mandatory surveillance
system. Infection Control and Hospital Epidemiology, 2008;29:21926.
48. Geubbels EL, et al. Promoting quality through surveillance of surgical site infections:
five prevention success stories. American Journal of Infection Control, 2004;32:424
30.
49. Rioux C, Grandbastien B, Astagneau P. Impact of a six-year control programme on
surgical site infections in France: results of the INCISO surveillance. Journal of
Hospital Infection, 2007;66:21723.
50. Wilson J, Ramboer I, Suetens C. Hospitals in Europe Link for Infection Control
through Surveillance (HELICS). Inter-country comparison of rates of surgical site
infection--opportunities and limitations. Journal of Hospital Infection, 2007;65(Suppl
2):16570.
51. Hutter MM, et al. Identification of surgical complications and deaths: an assessment
of the traditional surgical morbidity and mortality conference compared with the
American College of Surgeons National Surgical Quality Improvement Program.
Journal of the American College of Surgeons, 2006;203:61824.
52. Gawande AA, et al. An Apgar score for surgery. Journal of the American College of
Surgeons, 2007;204:2018.
53. Delilkan AE. Comparison of subjective estimates by surgeons and anaesthetists of
operative blood loss. British Medical Journal, 1972;ii:61921.
54. Gardiner AJ, Dudley HA. The measurement of blood loss at operation. British
Journal of Anaesthesia, 1962;34:6536.
55. Regenbogen SE, et al. Utility of the surgical Apgar score: validation in 4,119 patients.
Archives of Surgery, 2008 (accepted for publication).
56. Regenbogen SE, et al. Does the surgical Apgar score measure intraoperative
performance? Annals of Surgery, 2008 (accepted for publication).
57. Prasad SM, et al. Surgical Apgar: perioperative risk assessment for radical
cystectomy. Abstract presented at American Urologic Association Annual Meeting,
http://www.abstracts2view.com/aua/authorindex.php
Orlando,
Florida,
2008.
(accessed 15 May 2008).
151
SUMMARY OF RECOMMENDATIONS:
I.
II.
152
153
154
155
157
158
The Safe Surgery Saves Lives programme was established by the World
Alliance for Patient Safety as part of the World Health Organizations efforts
to reduce the number of surgical deaths across the globe. The aim of the
programme is to harness political commitment and clinical will to address
important safety issues, including inadequate anaesthetic safety practices,
avoidable surgical infection and poor communication among team members.
These have proved to be common, deadly and preventable problems in all
countries and settings.
INTRODUCTION:
159
Nearly all the steps will be checked verbally with the appropriate
personnel to ensure that the key actions have been performed. Therefore,
during the Sign In before induction of anaesthesia, the person coordinating
the checklist will verbally review with the patient (when possible) that his or
her identity has been confirmed, that the procedure and site are correct and
that consent for surgery has been given. The coordinator will visually confirm
that the operative site has been marked (if appropriate) and will verbally
review with the anaesthesia professional the patients risk of blood loss,
airway difficulty and allergic reaction and whether a full anaesthesia safety
check has been completed. Ideally the surgeon will be present for the Sign In,
as the surgeon may have a clearer idea of anticipated blood loss, allergies, or
other complicating patient factors. However, the surgeons presence is not
essential for completing this part of the checklist.
Having a single person lead the checklist process is essential for its
success. In the complex setting of an operating room, any of the steps may
be overlooked during the fast-paced preoperative, intraoperative, or
postoperative preparations. Designating a single person to confirm
completion of each step of the checklist can ensure that safety steps are not
omitted in the rush to move forward with the next phase of the operation.
Until team members are familiar with the steps involved, the checklist
coordinator will likely have to guide the team through this checklist process.
For the Sign Out, the team will review together the operation that
was performed, completion of sponge and instrument counts and the
labelling of any surgical specimens obtained. It will also review any
equipment malfunctions or issues that need to be addressed. Finally, the team
will review key plans and concerns regarding postoperative management and
recovery before moving the patient from the operating room.
For the Time Out, each team member will introduce him or
herself by name and role. If already partway through the operative day
together, the team can simply confirm that everyone in the room is known to
each other. The team will pause immediately prior to the skin incision to
confirm out loud that they are performing the correct operation on the
correct patient and site and then verbally review with one another, in turn,
the critical elements of their plans for the operation, using the checklist
questions for guidance. They will also confirm that prophylactic antibiotics
have been administered within the previous 60 minutes and that essential
imaging is displayed, as appropriate.
160
SIGN IN:
The Sign In is to be completed before induction of anaesthesia in
order to confirm the safety of proceeding. It requires the presence of the
anaesthesia professional and nursing personnel at the very least. The checklist
coordinator may complete this section all at once or sequentially, depending
on the flow of preparation for anaesthesia. The details for each of the boxes
in the Sign In are as follows:
The checklist coordinator should direct this and the next two
questions to the anaesthesia professional. First, the coordinator should ask
whether the patient has a known allergy and, if so, what it is. This should be
done even if he or she knows the answer in order to confirm that the
anaesthesia professional is aware of any allergies that pose a risk to the
patient. The appropriate box is then filled in. If the coordinator knows of an
allergy that the anaesthesia professional is not aware of, this information
should be communicated.
161
At this point the Sign In is completed and the team may proceed with anaesthetic
induction.
In this safety step, the coordinator asks the anaesthesia team whether
the patient risks losing more than half a litre of blood during surgery in order
to ensure recognition of and preparation for this critical event. Large volume
blood loss is among the most common and important dangers for surgical
patients, with risk of hypovolaemic shock escalating when blood loss exceeds
500 ml (7 ml/kg in children). Adequate preparation and resuscitation can
mitigate the consequences considerably.
Surgeons may not consistently communicate the risk of blood loss to
anaesthesia and nursing staff. Therefore, if the anaesthesia professional does
not know what the risk of major blood loss is for the case, he or she should
stop to discuss the risk with the surgeon before induction of anaesthesia. If
there is a significant risk of a greater than 500 ml blood loss, it is highly
recommended that at least two large bore intravenous lines or a central
venous catheter be placed prior to skin incision. In addition, the team should
confirm the availability of fluids or blood for resuscitation. (Note that the
expected blood loss will be reviewed again by the surgeon during the Time
Out. This will provide a second safety check for the anaesthesia professional
and nursing staff.)
DOES THE PATIENT HAVE A RISK OF >500 ML BLOOD LOSS (7 ML/KG IN CHILDREN)?
This step is the standard time out or surgical pause and meets
the standards of many national and international regulatory agencies. Just
before the surgeon makes the skin incision, the person coordinating the
checklist or another team member will ask everyone in the operating room to
stop and verbally confirm the name of the patient, the surgery to be
performed, the site of surgery and, where appropriate, the positioning of the
patient in order to avoid operating on the wrong patient or the wrong site.
For example, the circulating nurse might announce, Lets take our Time
Out, and then continue, Does everyone agree that this is patient X,
undergoing a right inguinal hernia repair? This box should not be checked
until the anaesthesia professional, surgeon and circulating nurse explicitly and
individually confirm agreement. If the patient is not sedated, it is helpful for
him or her to confirm the same as well.
CONFIRM ALL TEAM MEMBERS HAVE INTRODUCED THEMSELVES BY NAME AND ROLE
Time Out:
The Time Out is a momentary pause taken by the team just before
skin incision in order to confirm that several essential safety checks are
undertaken and involves everyone on the team.
162
The scrub nurse or technologist who sets out the equipment for the
case should verbally confirm that sterilization was performed and that, for
heat-sterilized instruments, a sterility indicator has verified successful
sterilization. Any discrepancy between the expected and the actual sterility
indicator results should be reported to all team members and addressed
before incision. This is also an opportunity to discuss any problems with
equipment and other preparations for surgery or any safety concerns the
scrub or circulating nurse may have, particularly ones not addressed by the
surgeon and anaesthesia team. If there are no particular concerns, however,
the scrub nurse or technologist can simply say, Sterility was verified. I have
no special concerns.
NURSING
staff and nursing staff of critical dangers and operative plans. This can be
done by simply asking each team member the specified question out loud.
The order of discussion does not matter, but each box should be checked
only after each clinical discipline has provided its information. During routine
procedures or those with which the entire team is familiar, the surgeon can
simply state, This is a routine case of X duration and then ask the
anaesthesia professional and nurse if they have any special concerns.
Sign Out:
The Sign Out should be completed before removing the patient
from the operating room. The aim is to facilitate the transfer of important
information to the care teams responsible for the care of the patient after
surgery. The Sign Out can be initiated by the circulating nurse, surgeon or
anaesthesia professional and should be accomplished before the surgeon has
At this point the Time Out is completed and the team may proceed with the operation.
163
SPONGE
AND
NEEDLE
COUNTS
ARE
CORRECT
(OR
NOT
SURGEON, ANAESTHESIA PROFESSIONAL AND NURSE REVEIW THE KEY CONCERNS FOR
RECOVERY AND MANAGEMENT OF THIS PATIENT
INSTRUMENT,
APPLICABLE)?
THAT
left the room. It can coincide, for example, with wound closure. Again, each
box should be checked only after the coordinator has confirmed that each
item has been addressed by the team.
With this final step, the safety checklist is completed. If desired, the checklist can be placed
in the patient record or retained for quality assurance review.
164
165
166
167
168
Meena Cherian, Department of Essential
Organization, Geneva, Switzerland
Health
Technologies,
World
Health
169
Olaiton Soyannwo, Department of Anaesthesiology, University of Ibadan, Ibadan, Nigeria
Julie Storr, World Alliance for Patient Safety, World Health Organization, Geneva,
Switzerland
Charles Vincent, Clinical Safety Research Unit, Imperial College of Science, Technology
and Medicine, London, England
Thomas Weiser, Department of Health Policy and Management, Harvard School of Public
Health, Boston, Massachusetts, United States
Andreas Widmer, Internal Medicine and Infection, Basel University, Basel, Switzerland
Iain Wilson, Department of Anaesthesia, Royal Devon and Exeter Hospital, Exeter,
England
David Wisner, Department of Surgery, University of California Davis, Sacramento,
California, United States
Kate Woodhead, Friends of African Nursing, Leeds, England
Acknowledgements for assistance
Rachel Davies, Department of Biosurgery and Surgical Technology, Imperial College of
Science, Technology and Medicine, London, England
Bryce Taylor, Department of Surgery, University of Toronto, Toronto, Ontario, Canada
Katherine Thompson, Department of Health Policy and Management, Harvard School of
Public Health, Boston, Massachusetts, United States
Acknowledgements for coordination and support
Hilary Coates, World Alliance for Patient Safety, World Health Organization, Geneva,
Switzerland
Martin Fletcher, National Patient Safety Agency, London, England
Helen Hughes, Patients for Patient Safety, World Alliance for Patient Safety, London,
England
Sooyeon Hwang, World Alliance for Patient Safety, World Health Organization, Geneva,
Switzerland
Claire Lemer, Department of Health, London, England
Fiona Stewart-Mills, World Alliance for Patient Safety, World Health Organization,
Geneva, Switzerland
Working group members
Bruce Barraclough, Chairman, New South Wales Clinical Excellence Commission,
Sydney, Australia
William Berry, Research Associate, Harvard School of Public Health, Boston,
Massachusetts, United States
Meena Cherian, Medical Officer, Emergency and Essential Surgical Care, Department of
Essential Health Technologies, World Health Organization, Geneva, Switzerland
Ara Darzi (Lead, Safe Surgical Teams working group), Parliamentary Under-Secretary at
the Department of Health, Department of Surgery, Imperial College of Science,
Technology and Medicine, London, England
170
E. Patchen Dellinger, Professor of Surgery, University of Washington Medical Center,
Seattle, Washington, United States
John Eichhorn, Professor, Department of Anesthesiology, University of Kentucky Medical
Center, Lexington, Kentucky, United States
Atul Gawande (Programme Leader), Associate Professor, Department of Health Policy
and Management, Harvard School of Public Health, Department of Surgery, Brigham
and Womens Hospital, Boston, Massachusetts, United States
Alex Haynes, Research Fellow, Harvard School of Public Health Boston, Massachusetts,
United States
Teodoro Herbosa, Associate Professor, Department of Surgery, Philippine General
Hospital, University of the Philippines, Manila, Philippines
Nongyao Katsatpibal, Professor, Faculty of Nursing, Chiang Mai University, Chiang Mai,
Thailand
Clifford Ko, Associate Professor, University of California at Los Angeles Center for
Surgical Outcomes, Los Angeles, California, United States
Lola Jean Kozak, Health Statistician (retired), National Center for Health Statistics,
Hyattsville, Maryland, United States
Martin Makary (Lead, Measurement working group), Associate Professor of Surgery,
John Hopkins University School of Medicine, Baltimore, Maryland, United States
Alan Merry (Lead, Safe Anaesthesia working group),
Anaesthesiology, University of Auckland, New Zealand
Head,
Department
of
Chancellor,
Martin
Luther
Christian
University,
Shillong,
Ali Sindi, Senior Adviser, Office of the Prime Minister, Kurdistan Regional Government,
Erbil, Iraq
Olaitan Soyannwo, Professor, Department of Anaesthesia, University of Ibadan, Nigeria
Julie Storr, Technical Officer, World Alliance for Patient Safety, World Health
Organization, Geneva, Switzerland
Thomas Weiser, Research Fellow,
Massachusetts, United States
Harvard
School
of
Public
Health,
Boston,
171
Kate Woodhead, Founder and Chairman of Trustees, Friends of African Nursing, Leeds,
England
Additional consultants
Jon Ahlberg, Landstingens msesidiga frskringsbolag, Sweden
Kurian Joseph Alappat, Asia and Oceania Federation of Obstetrics and Gynaecology,
India
Peter Angood, Joint Commission, United States
Irini Antoniadou, European Operating Room Nurses Association, Sweden
Marco Baldan, International Committee of the Red Cross, Switzerland
Consuelo Basili, Polyclinic Universital Hospital of Modena, Italy
Mohamed Saleh Ben Ammar, Hpital Mongi Slim, Tunisia
David Benton, International Council of Nurses, Switzerland
Karsten Boden, Swiss Federation of Nurses and Nurse Anaesthetists, Switzerland
Robert Brooks, American Association of Orthopaedic Surgery, United States
Anselmo Campagna, Polyclinic University Hospital of Modena, Italy
Catherine Chen, Johns Hopkins University School of Medicine, United States
Paul Craig, University of California San Diego Medical Center, United States
Richard Croteau, Joint Commission International, United States
Gauthier Desuter, Universit Catholique de Louvain, Belgium
Neelam Dhingra-Kumar, Blood Safety Team, Department of Essential Health
Technologies, World Health Organization, Geneva, Switzerland
Lena Dohlman, Massachusetts General Hospital, United States
Marita Eisenmann-Klein, International Confederation of Plastic Reconstructive and
Aesthetic Surgery, Germany
Bjrn Fahlgren, Devices and Clinical Technology, World Health Organization, Geneva,
Switzerland
Edmundo Ferraz, Federal Hospital of Pernambuco, Brazil
Abe Fingerhut, Centre Hospitalier Intercommunal, France
Tesfamicael Ghebrehiwet, International Council of Nurses, Switzerland
Aberra Gobezie, Debub University Referral Hospital, Ethiopia
172
Christine Goeschel, Johns Hopkins University School of Medicine, United States
Peter Crichton Gordon, University of Cape Town, South Africa
Linda Groah, Association of periOperative Registered Nurses, United States
Paul Hahnloser, International College of Surgeons, Switzerland
Felix Harder, International Society of Surgery, Switzerland
Phil Hassen, Canadian Patient Safety Institute, Canada
Awori Hayanga, Johns Hopkins University School of Medicine, United States
Ahmed Hazem Helmy, Theodore Bilharz Research Institute, Egypt
Jaap Hoekman, Dutch Association of Anaesthesia Workers, Netherlands
Andrei Issakov, Health Systems Policies and Operations, World Health Organization,
Geneva, Switzerland
Cosmas Kalwambo, Patient Advice and Liaison Service, Zambia
David Kennedy, University of Pennsylvania Health System, United States
Pattapong Kessomboon, Khon Kaen University, Thailand
Angela Lashoher, Johns Hopkins University School of Medicine, United States
David Loose, National Association for Healthcare Quality, United States
T.E. Madiba, University of KwaZulu-Natal, South Africa
Nana Yaw Manu, Bekwai District Hospital, Ghana
Charles Mock, Violence and Injury Prevention and Disability, World Health
Organization, Geneva, Switzerland
Joachim Nagel, International Union for Physical and Engineering Sciences in Medicine,
Germany
Sergelen Orgoi, Health Sciences University, Mongolia
C. Palanivelu, National Training Institute, India
Annette Pantle, New South Wales Clinical Excellence Commission, Australia
Gheorghe Peltecu, Filantropia Hospital, Romania
Wolfhart Puhl, European Federation of National Associations of Orthopaedics and
Traumatology, Switzerland
Jane Reid, Association for Perioperative Practice, England
Matthias Richter-Turtur, ChirurgieKreisklinik, Germany
Pascal Rod, International Federation of Nurse Anaesthetists, France
Hamid Rushwan, International Federation of Gynaecology and Obstetrics, England
Christopher Russell, Royal College of Surgeons of England, England
Daniel Scheidegger, University of Basel, Switzerland
Uwe Schulte-Sasse, Germany
J. Bryan Sexton, Johns Hopkins University School of Medicine, United States
Peter Sikana, United Nations Population Fund, Sierra Leone
Michael Stark, New European Surgical Academy, Germany
MaryJo Steiert, Association of periOperative Registered Nurses, United States
Grace Tang, Hong Kong Academy of Medicine, China
173
Bryce Taylor, University of Toronto, Canada
Gia Tomadze, Georgian Association of Transplantologists, Georgia
Isabeau Walker, Great Ormond Street Hospital, England
David Whitaker, Association of Anaesthetists of Great Britain and Ireland, England
Eize Wielinga, Rijnland Hospital, Netherlands
David Wilkinson, Department of Anaesthesia, St Bartholomews Hospital, England
David Wong, North American Spine Society, United States
Suzette Woodward, National Patient Safety Agency, England